The following data is part of a premarket notification filed by Regent Hospital Products with the FDA for Rubber Latex Surgeons Gloves.
Device ID | K910928 |
510k Number | K910928 |
Device Name: | RUBBER LATEX SURGEONS GLOVES |
Classification | Surgeon's Gloves |
Applicant | REGENT HOSPITAL PRODUCTS C/O ARENT-FOX-KINT-PLOTK-KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
Contact | Wayne H Matelski |
Correspondent | Wayne H Matelski REGENT HOSPITAL PRODUCTS C/O ARENT-FOX-KINT-PLOTK-KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-05 |
Decision Date | 1991-06-13 |