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 |