KUALA LUMPUR (Dec 2): Car leather upholstery maker Pecca Group Bhd, which announced its venture into personal protective equipment (PPE) production in late June, has been registered with the US Food and Drug Administration (FDA).
On top of this, its wholly-owned subsidiary Pecca Leather Sdn Bhd (PLSB) is also certified to comply with the European Union’s CE marking requirements. Thus, this enables Pecca to commence exports of its medical face masks to Asia, Europe and the US.
“Pecca’s facility is registered with the Medical Device Authority Malaysia and certified to meet ISO 13485:2016 Quality Management System requirements for the design, development and manufacturing of Personal Protective Equipment including 3-ply and N95 masks for surgical/medical and general use,” said the company in a filing with the local stock exchange.
Furthermore, Pecca’s face masks are manufactured in an ISO Class 8 cleanroom manufacturing facility, which is certified to meet ISO 14644-1 requirements for air cleanliness and airborne particulate count.
Pecca had commenced production of medical, surgical, and disposable face masks in August 2020 and has a production capacity of up to 20 million pieces per month currently.
The group aims to reach production capacity of 50 million pieces a month by early-2021.
Pecca had appointed Rentas Health Sdn Bhd as the sole distributor of its face masks, which are currently distributed under the ‘RH’ brand through various channels including medical and healthcare providers, hypermarkets and supermarkets, wholesalers, and retail stores.
Pecca’s shares closed one sen or 0.62% higher at RM1.61 today, valuing it at RM302.68 million. Year to date, the counter has gone up 46% from RM1.10.
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