The following data is part of a premarket notification filed by American Nitrile Operations Llc with the FDA for Sapphire Pro Powder-free Royal Blue Nitrile Exam Gloves.
| Device ID | K220825 |
| 510k Number | K220825 |
| Device Name: | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | American Nitrile Operations LLC 3500 Southwest Blvd Grove City, OH 43123 |
| Contact | Stephen Perrin |
| Correspondent | Stephen Perrin American Nitrile Operations LLC 3500 Southwest Blvd Grove City, OH 43123 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-21 |
| Decision Date | 2022-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850040723298 | K220825 | 000 |
| 10811220035447 | K220825 | 000 |
| 10811220035454 | K220825 | 000 |
| 10811220035461 | K220825 | 000 |
| 10811220035478 | K220825 | 000 |
| 00850040723250 | K220825 | 000 |
| 00850040723243 | K220825 | 000 |
| 00850040723106 | K220825 | 000 |
| 00850040723113 | K220825 | 000 |
| 00850040723304 | K220825 | 000 |
| 00850040723328 | K220825 | 000 |
| 00850040723069 | K220825 | 000 |
| 00850040723229 | K220825 | 000 |
| 00850040723236 | K220825 | 000 |
| 00850040723274 | K220825 | 000 |
| 00850040723281 | K220825 | 000 |
| 10811220035430 | K220825 | 000 |