LZA — Polymer Patient Examination Glove Class I
Classification Details
- Product Code
- LZA
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253160 | basic medical technology | Syntex Exam Gloves | January 23, 2026 |
| K252549 | kossan international | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tes | January 13, 2026 |
| K251141 | mercator medical (thailand) | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested | November 17, 2025 |
| K250861 | hartalega ngc sdn. bhd | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fe | October 23, 2025 |
| K252075 | program insite | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | October 17, 2025 |
| K251716 | basic medical technology | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid F | August 27, 2025 |
| K252244 | ever global (vietnam) enterprise corporation | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use Wit | August 21, 2025 |
| K243604 | o and m halyard | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, | August 18, 2025 |
| K251319 | hartalega ngc sdn. bhd | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy D | July 30, 2025 |
| K250193 | basic medical technology | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opi | July 9, 2025 |
| K250342 | encompass industries sdn. bhd | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with | July 8, 2025 |
| K250496 | zibo shengkun chemical industry co | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | July 7, 2025 |
| K243172 | o and m halyard | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple N | June 18, 2025 |
| K243133 | kl-kepong rubber products sdn. bhd | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for | June 17, 2025 |
| K243694 | mah sing healthcare sdn. bhd | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested f | June 6, 2025 |
| K243796 | glove one | GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use w | June 3, 2025 |
| K250630 | basic medical technology | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Ch | May 22, 2025 |
| K250944 | gmp medicare sdn. bhd | Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy | April 23, 2025 |
| K250578 | careglove global sdn. bhd | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & | April 1, 2025 |
| K250502 | safesource direct | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, | March 19, 2025 |