The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Public Co., Ltd. with the FDA for Polymer Coated, Chlorinated, Powder-free Latex Examination Gloves With Protein Labeling (less Than 50 Ug/g Per Glove).
Device ID | K040406 |
510k Number | K040406 |
Device Name: | POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) |
Classification | Latex Patient Examination Glove |
Applicant | SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
Contact | Janna P Tucker |
Correspondent | Janna P Tucker SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-17 |
Decision Date | 2004-05-14 |