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 |