The following data is part of a premarket notification filed by Carl Parker Associates, Inc. with the FDA for Sterile Surgical Gloves.
| Device ID | K891308 |
| 510k Number | K891308 |
| Device Name: | STERILE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | CARL PARKER ASSOCIATES, INC. 175M COMMERCE DR. P.O. BOX 12084 Hauppauge, NY 11788 |
| Contact | Carl Parker |
| Correspondent | Carl Parker CARL PARKER ASSOCIATES, INC. 175M COMMERCE DR. P.O. BOX 12084 Hauppauge, NY 11788 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-09 |
| Decision Date | 1989-04-26 |