The following data is part of a premarket notification filed by Shanghai Changzheng Latex Factory with the FDA for Latex Examination Glove Powder Free, With Protein Labeling Claim (50 Micrograms Or Less Total Water Soluble Protein).
| Device ID | K992031 |
| 510k Number | K992031 |
| Device Name: | LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN) |
| Classification | Latex Patient Examination Glove |
| Applicant | SHANGHAI CHANGZHENG LATEX FACTORY 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker SHANGHAI CHANGZHENG LATEX FACTORY 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-16 |
| Decision Date | 1999-07-12 |
| Summary: | summary |