The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Public Co., Ltd. with the FDA for Royal Guard.
| Device ID | K092617 |
| 510k Number | K092617 |
| Device Name: | ROYAL GUARD |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 6324 MEETING HOUSE WAY Alexandria, VA 22312 -1718 |
| Contact | Kok-kee Hon |
| Correspondent | Kok-kee Hon SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 6324 MEETING HOUSE WAY Alexandria, VA 22312 -1718 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-26 |
| Decision Date | 2010-05-20 |
| Summary: | summary |