The following data is part of a premarket notification filed by Globe Ent., Inc. with the FDA for Surgical Gloves.
| Device ID | K884622 |
| 510k Number | K884622 |
| Device Name: | SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | GLOBE ENT., INC. 8345 W. LITTLE YORK, # 1 Houston, TX 77040 |
| Contact | Andy Hu |
| Correspondent | Andy Hu GLOBE ENT., INC. 8345 W. LITTLE YORK, # 1 Houston, TX 77040 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-04 |
| Decision Date | 1989-03-14 |