The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Tru-touch Pf Vinyl Powder Free Examination Glove.
Device ID | K992122 |
510k Number | K992122 |
Device Name: | TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE |
Classification | Vinyl Patient Examination Glove |
Applicant | MAXXIM MEDICAL 477 COMMERCE BLVD. Oldsmar, FL 34677 |
Contact | Joyce Moody |
Correspondent | Joyce Moody MAXXIM MEDICAL 477 COMMERCE BLVD. Oldsmar, FL 34677 |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-23 |
Decision Date | 1999-07-15 |
Summary: | summary |