The following data is part of a premarket notification filed by Beijing Reagent Latex Products Co., Ltd. with the FDA for Snow Lotus Powder Free Latex Examination Gloves With A Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K010947 |
| 510k Number | K010947 |
| Device Name: | SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | BEIJING REAGENT LATEX PRODUCTS CO., LTD. PO BOX 4341 Crofton, MD 21114 |
| Contact | Christina Smith |
| Correspondent | Christina Smith BEIJING REAGENT LATEX PRODUCTS CO., LTD. PO BOX 4341 Crofton, MD 21114 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-29 |
| Decision Date | 2001-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16936610210137 | K010947 | 000 |
| 26936610210028 | K010947 | 000 |
| 16936610210038 | K010947 | 000 |
| 16936610210045 | K010947 | 000 |
| 16936610210052 | K010947 | 000 |
| 16936610210069 | K010947 | 000 |
| 16936610210076 | K010947 | 000 |
| 16936610210083 | K010947 | 000 |
| 16936610210090 | K010947 | 000 |
| 16936610210106 | K010947 | 000 |
| 16936610210113 | K010947 | 000 |
| 16936610210120 | K010947 | 000 |
| 26936610210011 | K010947 | 000 |