# Wear Safe Malaysia Sdn. Bhd.

- Location (FDA's records): Port Klang, Selangor, D.E., MY
- FDA decisions: 14 (1998–2017): 14 510(k) clearances
- Names in FDA's records: Wear Safe Malaysia Sdn. Bhd. (8); Wear Safe (Malaysia) Sdn. Bhd. (6)
- Product codes: LYY (7), KGO (3), LZA (3), LZC (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Northstar Healthcare Holdings: 2 (https://510kreport.com/company/northstar-healthcare-holdings)
- Top Calibre Sdn Bhd: 2 (https://510kreport.com/company/top-calibre-sdn-bhd)
- Wear Safe (Malaysia) Sdn Bhd - Facility II: 1 (https://510kreport.com/company/wear-safe-malaysia-sdn-bhd-facility-ii)
- Worldmed Manufacturing Sdn. Bhd.: 1 (https://510kreport.com/company/worldmed-manufacturing-sdn-bhd)

## Its most-cited devices
- K062917: Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50 (2006), cited by 2
- K093500: Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-Sterile (2010), cited by 1
- K090327: Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling Claim of 50 UG Per DM2 of Glove (2009), cited by 1
- K101799: Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling Claim of 50UG Per DM2 of Glove (2010), cited by 1
- K092492: Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling Claim of 50 Micrograms Per DM2 O (2009), cited by 1

## Recent decisions
- K172420: Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim (Sep 29, 2017)
- K101799: Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling Claim of 50UG Per DM2 of Glove (Sep 3, 2010)
- K093500: Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-Sterile (Jan 19, 2010)
- K092492: Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling Claim of 50 Micrograms Per DM2 O (Oct 21, 2009)
- K090066: Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling Claim of 50 Micrograms Per DM2 of Glove (May 15, 2009)
- K090327: Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling Claim of 50 UG Per DM2 of Glove (Apr 3, 2009)
- K062917: Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50 (Nov 2, 2006)
- K062778: Sterile Powder-Free Nitrile Patient Examination Glove, Blue Colored (Oct 27, 2006)

Source page: https://510kreport.com/company/wear-safe-malaysia-sdn-bhd