The following data is part of a premarket notification filed by Southland Products Co., Ltd. with the FDA for Southland Powderfree (polymer-coated) Latex Examination Gloves.
Device ID | K990751 |
510k Number | K990751 |
Device Name: | SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | SOUTHLAND PRODUCTS CO., LTD. 55 RAJYINDEE RD. Hatyai, Songkhla, TH 90110 |
Contact | Ng Peng Leong |
Correspondent | Ng Peng Leong SOUTHLAND PRODUCTS CO., LTD. 55 RAJYINDEE RD. Hatyai, Songkhla, TH 90110 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-08 |
Decision Date | 1999-03-23 |