The following data is part of a premarket notification filed by Pai Hoi Ent., Ltd. with the FDA for Patient Examination Gloves (latex).
Device ID | K891831 |
510k Number | K891831 |
Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
Classification | Latex Patient Examination Glove |
Applicant | PAI HOI ENT., LTD. 401 MCCORMICK ST. San Leandro, CA 94577 |
Contact | Young Park |
Correspondent | Young Park PAI HOI ENT., LTD. 401 MCCORMICK ST. San Leandro, CA 94577 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-24 |
Decision Date | 1989-09-01 |