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 |