The following data is part of a premarket notification filed by Carl Parker Associates, Inc. with the FDA for Defend Latex Examination Gloves.
Device ID | K891157 |
510k Number | K891157 |
Device Name: | DEFEND LATEX EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
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 | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-06 |
Decision Date | 1989-03-16 |