The following data is part of a premarket notification filed by Southland Products Co., Ltd. with the FDA for Patient Examination Gloves.
| Device ID | K901903 |
| 510k Number | K901903 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SOUTHLAND PRODUCTS CO., LTD. 10, JOOTEE UTHIT 1 ROAD HATYAI, SONGKHLA P.O. BOX 128 Thailand, TH |
| Contact | Thanasak Ghansuntee |
| Correspondent | Thanasak Ghansuntee SOUTHLAND PRODUCTS CO., LTD. 10, JOOTEE UTHIT 1 ROAD HATYAI, SONGKHLA P.O. BOX 128 Thailand, TH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-27 |
| Decision Date | 1990-05-18 |