The following data is part of a premarket notification filed by Globe Safety Products, Inc. with the FDA for Ambi-dex (latex Examination Gloves).
| Device ID | K890115 |
| 510k Number | K890115 |
| Device Name: | AMBI-DEX (LATEX EXAMINATION GLOVES) |
| Classification | Latex Patient Examination Glove |
| Applicant | GLOBE SAFETY PRODUCTS, INC. FLAT 1-11, 6TH FL. KAR WAH IND BLDG., Y.L.T.L. 356 YUEN LONG N.t. Hong Kong, GB |
| Contact | W. M Sung |
| Correspondent | W. M Sung GLOBE SAFETY PRODUCTS, INC. FLAT 1-11, 6TH FL. KAR WAH IND BLDG., Y.L.T.L. 356 YUEN LONG N.t. Hong Kong, GB |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-11 |
| Decision Date | 1989-09-01 |