The following data is part of a premarket notification filed by Ansell Perry with the FDA for Non-sterile E.p. Latex Examination Glove.
| Device ID | K982453 |
| 510k Number | K982453 |
| Device Name: | NON-STERILE E.P. LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | ANSELL PERRY 1875 HARSH AVE. S.E. Massillon, OH 44646 -7199 |
| Contact | James R Chatterton |
| Correspondent | James R Chatterton ANSELL PERRY 1875 HARSH AVE. S.E. Massillon, OH 44646 -7199 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1998-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817643022456 | K982453 | 000 |
| 00817643021602 | K982453 | 000 |
| 00817643021619 | K982453 | 000 |
| 00817643021626 | K982453 | 000 |
| 00817643021633 | K982453 | 000 |
| 00817643021640 | K982453 | 000 |
| 00817643021657 | K982453 | 000 |
| 00817643021664 | K982453 | 000 |
| 00817643021688 | K982453 | 000 |
| 00817643021695 | K982453 | 000 |
| 00817643021985 | K982453 | 000 |
| 00817643021992 | K982453 | 000 |
| 00817643022005 | K982453 | 000 |
| 00817643022012 | K982453 | 000 |
| 00817643021596 | K982453 | 000 |