The following data is part of a premarket notification filed by Hong Huang Tang Industrial Co., Ltd. with the FDA for Prepowder Vinyl Patient Examination Gloves.
| Device ID | K962026 |
| 510k Number | K962026 |
| Device Name: | PREPOWDER VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HONG HUANG TANG INDUSTRIAL CO., LTD. 34 LINNELL CIRCLE Billerica, MA 01821 |
| Contact | Huan Chung Li |
| Correspondent | Huan Chung Li HONG HUANG TANG INDUSTRIAL CO., LTD. 34 LINNELL CIRCLE Billerica, MA 01821 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-23 |
| Decision Date | 1996-09-10 |