# Careplus (M) Sdn Bhd

- Location (FDA's records): Seremban, MY
- FDA decisions: 10 (2015–2021): 10 510(k) clearances
- Product codes: KGO (4), LZA (3), LYY (2), LZC (1)
- 510(k) review time since 2016: median 207 days, against 194 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 8 (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
- Ansell Perry: 1 (https://510kreport.com/company/ansell-perry)
- Wear Safe (Malaysia) Sdn Bhd - Facility II: 1 (https://510kreport.com/company/wear-safe-malaysia-sdn-bhd-facility-ii)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)

## Firms that cite its devices most
- Careglove Global Sdn. Bhd.: 3 (https://510kreport.com/company/careglove-global-sdn-bhd)
- Shanxi Hongjin Plastic Technology Co., Ltd.: 1 (https://510kreport.com/company/shanxi-hongjin-plastic-technology)
- Grand Work Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/grand-work-plastic-products)

## Its most-cited devices
- K152593: Latex Examination Glove Powder Free (2016), cited by 2
- K142862: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). (2015), cited by 2
- K202765: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (2021), cited by 1
- K142858: POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) (2015), cited by 1
- K201857: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (2021), cited by 1
- K162858: Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest (2017), cited by 1

## Recent decisions
- K211621: Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) (Oct 6, 2021)
- K203705: Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) (Aug 20, 2021)
- K201857: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (Aug 20, 2021)
- K210724: ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs (Aug 3, 2021)
- K210656: ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs (Jun 24, 2021)
- K202765: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (May 27, 2021)
- K162858: Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest (Jul 24, 2017)
- K152593: Latex Examination Glove Powder Free (Feb 25, 2016)

Source page: https://510kreport.com/company/careplus-m-sdn-bhd