The following data is part of a premarket notification filed by Care-pro Industries, Inc. with the FDA for Non-sterile Patient Examination Gloves.
Device ID | K892772 |
510k Number | K892772 |
Device Name: | NON-STERILE PATIENT EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | CARE-PRO INDUSTRIES, INC. 16 GILLMAN ST. Irvine, CA 92715 |
Contact | Felita R Gonzalez |
Correspondent | Felita R Gonzalez CARE-PRO INDUSTRIES, INC. 16 GILLMAN ST. Irvine, CA 92715 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-13 |
Decision Date | 1989-08-04 |