The following data is part of a premarket notification filed by Rising Crown Industries Ltd. with the FDA for Patient Examination Gloves (latex).
Device ID | K892091 |
510k Number | K892091 |
Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
Classification | Latex Patient Examination Glove |
Applicant | RISING CROWN INDUSTRIES LTD. FLAT A7-A9, BLK "A". 10/F. HONG KONG IND CENTRE 489-491 Castle Peak Rd. Kowloon, HK |
Contact | Ying Choi |
Correspondent | Ying Choi RISING CROWN INDUSTRIES LTD. FLAT A7-A9, BLK "A". 10/F. HONG KONG IND CENTRE 489-491 Castle Peak Rd. Kowloon, HK |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-03 |
Decision Date | 1989-12-11 |