Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
K200633 is the FDA 510(k) clearance record for Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove, a class I device, cleared for 0 & M Halyard, Inc. on under FDA product code LZC (Medical Glove, Specialty). FDA's definition for product code LZC reads: "A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition...". FDA records list one 510(k) clearance for 0 & M Halyard, Inc. As of , FDA records show no recalls naming K200633.
Clearance record
- Decision date
- Received
- (215 days to decision)
- Product code
- LZC Medical Glove, Specialty
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- 0 & M Halyard, Inc. 5405 Windward Pkwy., Alpharetta GA
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code LZC
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 1 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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