# Jr Engineering & Medical Technologies (M) Sdn. Bhd.

- Location (FDA's records): Hulu Selangor, MY
- FDA decisions: 10 (2019–2023): 10 510(k) clearances
- Product codes: LZA (4), KGO (2), LZC (2), LYY (2)
- 510(k) review time since 2016: median 150 days, against 111 for FDA's reviews in the same codes and years (2 of 9 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 36 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mercator Medical (Thailand), Ltd.: 2 (https://510kreport.com/company/mercator-medical-thailand)
- Beta Healthcare Products Pvt., Ltd.: 1 (https://510kreport.com/company/beta-healthcare-products-pvt)
- O&M Halyard, Inc.: 1 (https://510kreport.com/company/o-m-halyard)
- Northstar Healthcare Holdings: 1 (https://510kreport.com/company/northstar-healthcare-holdings)
- Harbour Health, LLC: 1 (https://510kreport.com/company/harbour-health)
- Primus Gloves Pvt Limited: 1 (https://510kreport.com/company/primus-gloves-pvt)

## Firms that cite its devices most
- Aspen Glove Sdn. Bhd.: 3 (https://510kreport.com/company/aspen-glove-sdn-bhd)
- Amazing Rubber Products Pvt, Ltd.: 3 (https://510kreport.com/company/amazing-rubber-products-pvt)
- Hi-Care Thai Gloves Co., Ltd.: 2 (https://510kreport.com/company/hi-care-thai-gloves)
- Pentavest Holdings Sdn Bhd: 2 (https://510kreport.com/company/pentavest-holdings-sdn-bhd)
- Goodgloves Industries Sdn Bhd: 1 (https://510kreport.com/company/goodgloves-industries-sdn-bhd)
- Phu Duc Huy Production Trading Services Corporation: 1 (https://510kreport.com/company/phu-duc-huy-production-trading-services)
- Safeskin Retailing (Hk) Limited: 1 (https://510kreport.com/company/safeskin-retailing-hk)
- Clover Glove Company Limited: 1 (https://510kreport.com/company/clover-glove)

## Its most-cited devices
- K192333: Blue Nitrile Examination Gloves Powder Free (2020), cited by 24
- K192329: Blue Latex Examination Powder Free Gloves (2019), cited by 6
- K192328: JR.MEDIK Latex Surgeon’s Gloves Powder Free (2020), cited by 5
- K221169: JR MEDIC Nitrile Examination Gloves Powder Free- Black (2022), cited by 1

## Recent decisions
- K222350: Sterile Nitrile Surgical Gloves Powder Free (Apr 13, 2023)
- K221626: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate (Dec 7, 2022)
- K222348: JR Medic (Oct 27, 2022)
- K221169: JR MEDIC Nitrile Examination Gloves Powder Free- Black (Oct 25, 2022)
- K222349: JR MEDIC  Nitrile Examination Gloves Powder Free (Orange, Purple) (Oct 21, 2022)
- K221157: JR Medic (Aug 30, 2022)
- K212827: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs (Dec 6, 2021)
- K192328: JR.MEDIK Latex Surgeon’s Gloves Powder Free (Mar 10, 2020)

Source page: https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd