510(k) K122727
- Device
- BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
- Applicant
- NORTHSTAR HEALTHCARE HOLDINGS
- 510(k) number
- K122727
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-02-22
- Date received
- 2012-09-05
- Regulation
- 880.6250
- Classification name
- Polymer Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- MICHAEL RIORDAN
- Address
- 70 Sir John Rogersons Quay Dublin 2 IE -- --
FDA Registration Numbers#
- 3003699698
- 3007407626
- 3015335977
- 3033715710
- 1121142
- 3044819802
- 1222115
- 3031181949
- 3031180726
- 1250045
- 3011862887
- 3019798835
- 3015128453
- 3038284237
- 2183301
- 3009503464
- 3009496643
- 9616896
- 3013998568
- 3005034064
- 3021233711
- 3021591322
- 3032026388
- 3005885230
- 3015335034
- 3011647251
- 3007502227
- 3011658061
- 1649518
- 3008840959
- 3021641087
- 3007471500
- 3023917
- 3000247873
- 3010621964
- 3010895961
- 9680622
- 3038277359
- 3006534695
- 3024999439
- 3010195579
- 3011189071
- 3011200663
- 1937310
- 3006552561
- 3003120666
- 9617444
- 3013530281
- 3019252794
- 3013557562
- 2648727
- 8041150
- 3019944216
- 3038187455
- 3009474977
- 9610406
- 9680794
- 3008261717
- 3016785252
- 8043848
- 3022543478
- 3008427684
- 3003887292
- 3028652705
- 3011211126
- 3008395508
- 3005558160
- 9681151
- 3009218271
- 3010600155
- 3017171460
- 3006157842
- 3038276731
- 3013681444
- 3008700497
- 3023191174
- 3005568780
- 3015537296
- 3022538552
Source Documents#
Other 510(k) Records For Product Code LZA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | 2026-07-21 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue | Hartalega NGC Sdn. Bhd. | 2026-07-20 |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | 2026-06-24 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | 2026-06-03 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | 2026-01-13 |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |
| K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | 2025-10-17 |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. | 2025-08-27 |
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | O&M Halyard, Inc. | 2025-08-18 |
Legacy Summary#
summary
FDA Review#
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