The following data is part of a premarket notification filed by Care-pro Industries, Inc. with the FDA for Surgeon's Gloves.
Device ID | K892495 |
510k Number | K892495 |
Device Name: | SURGEON'S GLOVES |
Classification | Surgeon's Gloves |
Applicant | CARE-PRO INDUSTRIES, INC. 10605 BOOMER CIRCLE SUITE 101 Dallas, TX 75238 |
Contact | Alex Lai |
Correspondent | Alex Lai CARE-PRO INDUSTRIES, INC. 10605 BOOMER CIRCLE SUITE 101 Dallas, TX 75238 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-13 |
Decision Date | 1989-10-11 |