# Northstar Healthcare Holdings

- Location (FDA's records): Hamilton, Bermuda, IE
- FDA decisions: 10 (2011–2013): 10 510(k) clearances
- Names in FDA's records: Northstar Healthcare Holdings (9); Northstar Healthcare Holdings Limited (1)
- Product codes: LZA (6), LYY (3), LZC (1)
- Predicates its devices cite: 10 (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 whose devices it cites most
- Smart Glove Corp. Sdn Bhd: 3 (https://510kreport.com/company/smart-glove-sdn-bhd)
- Wear Safe Malaysia Sdn. Bhd.: 2 (https://510kreport.com/company/wear-safe-malaysia-sdn-bhd)
- Top Glove Sdn. Bhd.: 1 (https://510kreport.com/company/top-glove-sdn-bhd)
- Hartalega Sdn Bhd: 1 (https://510kreport.com/company/hartalega-sdn-bhd)
- Kossan Latex Industries (M)Sdn Bhd: 1 (https://510kreport.com/company/kossan-latex-industries-m-sdn-bhd)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)
- Gx Corporation Sdn Bhd: 1 (https://510kreport.com/company/gx-sdn-bhd)

## Firms that cite its devices most
- Assurguard Sdn. Bhd.: 2 (https://510kreport.com/company/assurguard-sdn-bhd)
- Primus Gloves Pvt Limited: 1 (https://510kreport.com/company/primus-gloves-pvt)
- Kossan International Sdn Bhd: 1 (https://510kreport.com/company/kossan-international-sdn-bhd)
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.: 1 (https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd)
- Puyang Linshi Health Co., Ltd.: 1 (https://510kreport.com/company/puyang-linshi-health)

## Its most-cited devices
- K121947: Ets Blue Powder-Free Patient Nitrile Examination Gloves (2012), cited by 2
- K112988: Powder Free Latex Patient Exam Glove with Protein Labeling Claim (50 Micrograms Per DM Squared or Less of Water Soluble (2011), cited by 1
- K121529: Black Nitrile Powder-Free Examination Gloves (2012), cited by 1
- K121926: Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with Protein Labling Claim (50UG/DM (2012), cited by 1
- K121464: Blue Power Free Nitrile Examination Glove (2012), cited by 1

## Recent decisions
- K122727: Blue Sterile Powder Free Nitrile Examination Glove (Feb 22, 2013)
- K122788: Textured, Natural to Off-White, Latex, Sterile, Powder Free Examination Gloves, with Protein Labeling Claim (50 UG/DM2 O (Jan 17, 2013)
- K123026: Textured, Blue, Latex, Powder Free Examination Glvoes, with Protein Labeling Claim (50UG/DM or Less of Water Soluble Pro (Nov 16, 2012)
- K122998: Blue Powdered Nitrile Examination Glove (Nov 6, 2012)
- K121926: Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with Protein Labling Claim (50UG/DM (Sep 20, 2012)
- K121947: Ets Blue Powder-Free Patient Nitrile Examination Gloves (Sep 10, 2012)
- K121529: Black Nitrile Powder-Free Examination Gloves (Jul 12, 2012)
- K121464: Blue Power Free Nitrile Examination Glove (Jul 5, 2012)

Source page: https://510kreport.com/company/northstar-healthcare-holdings