The following data is part of a premarket notification filed by American Bantex Corp. with the FDA for Bantex Surgical Latex Gloves- Type 1 Natural Rubber Latex Surgicsl Gloves, Sterile.
| Device ID | K963218 |
| 510k Number | K963218 |
| Device Name: | BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE |
| Classification | Surgeon's Gloves |
| Applicant | AMERICAN BANTEX CORP. 1640 ROLLINS RD. Burlingame, CA 94010 -2302 |
| Contact | Chee Keong Chow |
| Correspondent | Chee Keong Chow AMERICAN BANTEX CORP. 1640 ROLLINS RD. Burlingame, CA 94010 -2302 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-16 |
| Decision Date | 1996-10-30 |