The following data is part of a premarket notification filed by Nature's Farm Products (thailand) Co., Ltd. with the FDA for Patient Examination Gloves (latex).
Device ID | K892701 |
510k Number | K892701 |
Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
Classification | Latex Patient Examination Glove |
Applicant | NATURE'S FARM PRODUCTS (THAILAND) CO., LTD. 61, NATURE'S FARM HOUSE, SOI RAMKHAMHAENG 46 RAMKHAMHAENG Huamark Bangkok 10240, TH |
Contact | William Tai |
Correspondent | William Tai NATURE'S FARM PRODUCTS (THAILAND) CO., LTD. 61, NATURE'S FARM HOUSE, SOI RAMKHAMHAENG 46 RAMKHAMHAENG Huamark Bangkok 10240, TH |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-11 |
Decision Date | 1989-06-06 |