The following data is part of a premarket notification filed by Medical Glove Co., Ltd with the FDA for Pro Guard Nitrile Powder Free Examination Glove.
| Device ID | K213934 |
| 510k Number | K213934 |
| Device Name: | Pro Guard Nitrile Powder Free Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Medical Glove Co., Ltd 288, Moo 7, Tambon Lam Thap, TH 81190 |
| Contact | Teoh Choh Shee |
| Correspondent | Teoh Choh Shee Medical Glove Co., Ltd 288, Moo 7, Tambon Lam Thap, TH 81190 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-16 |
| Decision Date | 2022-08-06 |