Posted by koolset > 2021-02-05 20:19 | Report Abuse

Errr hotstuff, if I were you. I would delete your comments. This cert is good enough for the company to export good to US.

Posted by koolset > 2021-02-05 20:21 | Report Abuse

I am in this line that requires fda so I know.

Posted by strattegist > 2021-02-05 20:26 | Report Abuse

iya laaa... good enough to export... BUT... belom export lagiii...
bila mau export???... how many produced???... when to publish
production report?.. kui kui kui... we want substance not the
form maaaa...

Posted by asasri > 2021-02-05 20:29 | Report Abuse

Wow glove AT eksport ke USA

Posted by asasri > 2021-02-05 20:30 | Report Abuse

Ini kali betui betul terbang

Posted by oskchoon > 2021-02-05 20:32 | Report Abuse

Next week watch the opening price and daily trading volumes, if next Monday closed green with more than 500m trading volume then a small rally for CNY is possible,... Good luck..

Posted by oskchoon > 2021-02-05 20:33 | Report Abuse

AT - 11月穷12月绝今年就翻身....二月包赢大紅包....

Posted by ocs5858 > 2021-02-05 20:38 | Report Abuse

Fasten your seat belt !

Posted by Goodprofit > 2021-02-05 20:46 | Report Abuse

Consolidated soon

Posted by KK > 2021-02-05 21:06 | Report Abuse

Wow can export to US market now..so CNY rally coming?

Posted by kc02245 > 2021-02-05 21:06 | Report Abuse

C. Patient Examination Gloves (FDA Guidelines during the COVID-19 outbreak)

A non-powdered patient examination glove is a disposable device intended for a medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

These devices are class I (reserved) and subject to premarket notification requirements under section 510(k) of the FD&C Act because general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device and the devices are intended for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury, under sections 513(a)(1)(A) and 510(l)(1) of the FD&C Act. In general, FDA recommends that health care providers follow current Centers for Disease Control and Prevention (CDC) guidance regarding PPE that should be used during the COVID-19 outbreak. Health care employers must also comply with standards of OSHA that require PPE to protect workers and that apply to infectious disease hazards.

FDA recognizes the urgent need during the COVID-19 public health emergency for patient examination gloves due to increased use and demand which has led to shortages in their availability.

To help ensure the availability of these devices during the COVID-19 public health emergency, FDA DOES NOT intend to object to the distribution and use of patient examination gloves that do not comply with the following regulatory requirements, where the gloves do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81, Registration and Listing requirements in 21 CFR 807, Quality System Regulation requirements in 21 CFR 820, reports of corrections and removals in 21 CFR Part 806, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently believes such devices would not create such an undue risk where:

• The product includes labeling that accurately describes the product as an “unpowdered glove” (as opposed to a surgeon’s or patient examination glove), accurately describes its sterility status when individually packaged (non-sterile), does not claim the product as being free of a specific material (e.g., latex free), and includes a list of the body contacting materials;

• The product includes labeling with general statements and makes recommendations that would reduce sufficiently the risk of use, for example, a general statement about devices that have not been cleared by FDA and recommendations against use: when FDA-cleared gloves are available, in surgical settings or where significant exposure to liquid bodily or other hazardous fluids may be expected, and in clinical settings where the infection risk level is high; and

• The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses with chemotherapy drugs, fentanyl, and other opioids, uses for allergy or dermatitis prevention, uses for antimicrobial or antiviral protection, or uses for infection prevention or reduction.

Posted by kc02245 > 2021-02-05 21:11 | Report Abuse

AT SYSTEMATIZATION BERHAD Announcement details

Type Announcement
Subject OTHERS

Description
AT SYSTEMATIZATION BERHAD ("ATS" OR THE "COMPANY")
REGISTRATION OF AT GLOVE ENGINEERING SDN. BHD. A WHOLLY OWNED SUBSIDIARY OF THE COMPANY WITH THE U.S. FOOD AND DRUG ADMINISTRATION

The Board of Directors of AT Systematization Berhad (“ATS” or the “Company”) is pleased to inform that AT Glove Engineering Sdn. Bhd. (“AGESB”), a wholly owned subsidiary of the Company had on 1 February 2021 received the establishment registration with the Food and Drug Administration of the United States (“FDA”).

The disposable gloves are classified as medical devices and are subject to full FDA certification before it can be sold, to ensure the safety and effectiveness of the gloves.

Pursuant to a guidance issued by the FDA in March 2020, in view of the ongoing COVID-19 pandemic, the FDA DOES NOT object the distribution and use of gloves which has yet to comply with the regulatory requirements for full FDA certification, provided that the gloves are labelled in accordance with the guidelines issued by the FDA.

Following the receipt of establishment registration with FDA, AGESB can now export its medical examination gloves to the United States.

This announcement is dated 5 February 2021.

Posted by Beast3 > 2021-02-05 21:30 | Report Abuse

Retailer will stuck again. Good luck

Posted by trade101 > 2021-02-05 21:57 | Report Abuse

whatever announcement is not good enough for them..haters gonna hate, thats up to them..believers are not obligated to proof anything..have faith in what u guys invest..afterall its your money..

Posted by oskchoon > 2021-02-05 22:30 | Report Abuse

One good news today is AT awarded FDA certificate to export medical gloves to United States, and two bad news is MTouche announced Shares consolidation exercise of 10 shares becomes 1 share, another one is Vizione proposed private placement shares at 0.205.. Trade cautiously on Monday and good luck...

Posted by usedor1 > 2021-02-05 23:49 | Report Abuse

hahaha this new development shows none of you ATian knows how to read. Hello, this is not approval la ok, they're just applying only. Any tom dick and harry can apply.

Posted by Oldmantc > 2021-02-06 00:01 | Report Abuse

Oskchoon.. Your comment is misleading. FDA certificate is not granted yet.
The one that is being circulated is a document issued by their US agent (FDA Basics LLC).

Posted by Oldmantc > 2021-02-06 00:02 | Report Abuse

Do your own google research to find out more details

Posted by usedor1 > 2021-02-06 00:08 | Report Abuse

Oldmantc: this is the mentality of ATians, all of them delusional, desperate for any good news for AT to become 30 cents again, so they can finally get out of their penthouse because they bought during the KYY hype

Posted by JK22 > 2021-02-06 00:14 | Report Abuse

What ever AT did or progress, there are always some come out with hate and negative comment. If have no believe or holding why bother to comment or it is a nature in some who dislike to see other prosper. Becareful. That is a bad habit which will eat up oneself.

Posted by usedor1 > 2021-02-06 00:18 | Report Abuse

Call me a hater all you want, delusional people. I'm just here to watch the shitshow. Real entertaining watching you all patting yourselves on the back congratulating yourselves when today's news came out. None of you even actually read the announcement

Posted by onthewaytoforbes > 2021-02-06 01:21 | Report Abuse

Based on the chart the seller is lower than the buyer volume. Mean still got many trader/investor still holding and not willing to sell and still have many people willing to trade/invest on this stocks. In short-term this stock will give you disappointment. For medium-term to long-term you will never regret. Just buy and keep and you don't need to monitor the price movement daily to give you disappointment. If you want fast money then focus on other stocks first.

Posted by kc02245 > 2021-02-06 05:22 | Report Abuse

usedor1 hahaha this new development shows none of you ATian knows how to read. Hello, this is not approval la ok, they're just applying only. Any tom dick and harry can apply.
05/02/2021 11:49 PM

Oldmantc Oskchoon.. Your comment is misleading. FDA certificate is not granted yet.
The one that is being circulated is a document issued by their US agent (FDA Basics LLC).
06/02/2021 12:01 AM

===================================================================
FDA is allowing any glove company to just register and sell medical gloves in the USA due to the shortages caused by Covid-19. AGESB DOES NOT need any FDA approval at this time, but proper labelings are required.

As AGESB is now registered, it can start selling medical gloves to the USA with proper labeling guidelines from FDA.
=================================================================

Posted by oskchoon > 2021-02-06 08:59 | Report Abuse

AT - 11月穷12月绝今年就翻身....二月包赢大紅包....

Posted by asasri > 2021-02-06 09:19 | Report Abuse

Next week up

Posted by Reap88 > 2021-02-06 09:47 | Report Abuse

In recent months no filing to Bursa of any AT directors acquiring more shares. If AT is undervalued, revenue will increase or have potential to reach RM0.50 I am sure directors will give notice to trade & acquire from open market. Directors by right should be even more excited than us of AT potential.

Posted by KK > 2021-02-06 09:54 | Report Abuse

https://www.straitstimes.com/world/pandemic-could-end-in-7-years-at-current-pace-of-vaccination

Posted by EmperorFund > 2021-02-06 10:22 | Report Abuse

7 years of demand

When will life return to normal? In 7 years, at current vaccine rates

https://www.google.com/amp/s/www.nst.com.my/amp/world/world/2021/02/663322/when-will-life-return-normal-7-years-current-vaccine-rates

Posted by Makoijo > 2021-02-06 10:24 | Report Abuse

sek mg duk balah gapo gak weekend2 ni rehat la bohh
ejah make nasi kak wok ko nasi dage atas tol ko..perghh nyakut bosss
news gapo gak wat tubek ni? Acu try jual dulu gak biar naik 1 sen gak dulu baru nk gege
bo setakat FDA tu gak. Amerika dok pande eh nk beli bare glove malaysia. hahaha

jange duk harap sangat deh ATIan, nnti frust nunggeng nyo tubek tahik la ahahah
Kawe pese doh ni, jgne duk harap sangat news ni.
kalo demo duk ikut woh bual puak atians ni alamatnyo nunggeng nyo laa. make tahik guu

Posted by limit_up > 2021-02-06 10:34 | Report Abuse

Asaari Terbang

Posted by asasri > 2021-02-06 10:34 | Report Abuse

Amerika suka barang buatan Malaysia

Posted by asasri > 2021-02-06 10:36 | Report Abuse

Untung besar AT

Posted by KK > 2021-02-06 10:51 | Report Abuse

Share price up or down will depend on demand and supply , with the 7 years demand in glove supply you can imagine the growth rate & prospect of the company. Increase in demand of glove is a fact , speed up in vaccination rate is also a fact but this do not contradict each other. As reported in CNN news Biden's administration is aware of the shortage of PPE & glove in the present situation in US and this is the reason for open to more company for importing of glove .AT is one of the beneficial from this ruling and the company is expose to US huge market . Just think logically, judge and invest wisely on your investment plan.

Posted by Taipan > 2021-02-06 11:27 | Report Abuse

Just released 20 hours ago.

Pfizer withdraws application for emergency use of its Covid-19 Vaccine in India.

Read more at:
http://timesofindia.indiatimes.com/articleshow/80702294.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

Posted by Taipan > 2021-02-06 11:27 | Report Abuse

India is known as the Pharmaceutical for the World. India has been developing Vaccines for more than 30 years. India has emerged as one of the leading manufacturers of vaccines worldwide, and supplies large quantities of basic and advanced vaccines across the globe – 60% of global vaccine.

So why is Pfizer withdrawing their application from the worlds 2nd largest population?

Did India ask the right question?

Was Pfizer unable to provide the required data?
According to the article, Pfizer’s response was - " Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”

India's Central Drugs Standard Control Organisation had declined to accept Pfizer's request for approval without a small local trial on the vaccine's safety and immunogenicity for Indians

Isn’t this a requirement in most countries? To have a local trial on the vaccine safety and immunogenicity .

Posted by Apple888 > 2021-02-06 13:01 | Report Abuse

Can get ang pow before cny or not?

Posted by Teh Diven > 2021-02-06 13:23 | Report Abuse

50 cts 50 cts..1 pcs margin 50 cts...very good profit

Posted by 145921_wjy > 2021-02-06 13:26 | Report Abuse

Wow...Suddenly so many people here to support?!
that is mean still still still not the timing to buy...will come again next month..

Posted by spicyketchup > 2021-02-06 13:31 | Report Abuse

Progress, that's all you need to see and progress has been shown from time to time from AT. If still in doubt just buy 1 lot just for the learning process and reminder that i3 full of nonsense haters.
Price moving to next tier soon i believe.

Posted by wiseman888 > 2021-02-06 14:01 | Report Abuse

Apparently AT is showing some real progress in glove industry now. Not bad, keep it up.

Posted by asasri > 2021-02-06 14:14 | Report Abuse

Yes yes yes

Posted by rielza > 2021-02-06 14:54 | Report Abuse

Makoijo hahahahaha..nok g make nasi dage rano boh.. Mco.. Lamo xpekeno nasi dage atas tol ni...kikikiki

Posted by izoklse > 2021-02-06 17:19 | Report Abuse

pergh AT now can export to US Market giler la AT. Power.

Posted by jasman78 > 2021-02-06 18:44 | Report Abuse

Saya pernah masuk ATIans but I left, ramai yg tak rasional dalam tu asyik cakap 50 sen lepas tu RM1, hakikatnya semakin hari semakin jatuh, share 4 billion even top 5 dlm 3 mggu tak lepas 20 sen

Posted by strattegist > 2021-02-06 18:58 | Report Abuse

manyok kesiang niii weiii... nok wat guana..

Posted by Teh Diven > 2021-02-06 20:22 | Report Abuse

Slow slow naik sudah cantik

Posted by Teh Diven > 2021-02-06 20:22 | Report Abuse

Keep for long term

Posted by asasri > 2021-02-06 20:32 | Report Abuse

AT terbang ke amerika

Posted by strattegist > 2021-02-06 21:27 | Report Abuse

Asasri Tersangkut kat pokok nyior kaaa..

Posted by markian92 > 2021-02-06 21:33 | Report Abuse

if you see the chart, every 3 months AT will spike..