The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Patient Examination Gloves (latex).
Device ID | K891736 |
510k Number | K891736 |
Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
Classification | Latex Patient Examination Glove |
Applicant | QUEST INTL., INC. 521 ALA MOANA BLVD., #216 Honolulu, HI 96813 |
Contact | Richard Lim |
Correspondent | Richard Lim QUEST INTL., INC. 521 ALA MOANA BLVD., #216 Honolulu, HI 96813 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-22 |
Decision Date | 1989-05-25 |