FDA Device Registration & Listing · Union City, CA, US · Registration 2939935
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-05-08 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2018-04-05 |
| FMC | Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2007-11-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-01-30 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2023-01-30 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2018-03-07 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2007-11-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2021-12-17 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2017-09-25 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-12-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-01-31 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-08-05 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2020-08-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-12-12 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-12-12 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2021-04-23 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2018-04-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-08-05 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2017-09-25 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2017-09-25 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-08-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-12-12 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2019-12-12 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-08-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-03-21 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2023-03-21 |
No official correspondent registered.
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K212801 | Hong Seng Gloves Sdn Bhd | Powder free nitrile examination glove- black, non sterile | 2022-01-09 |
| K260806 | Vista Industries,, LLC | Nitrile Disposable Examination Gloves | 2026-06-03 |
| K011593 | Ansell Healthcare Products, Inc. | MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE | 2001-06-21 |
| K981039 | Sri Johani Sdn. Bhd. | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | 1998-04-21 |
| K101595 | Better Care Plastic Technology Cp., Ltd. | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | 2010-08-06 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3030671502 | GUANGDONG VYIMED CO., LTD. | Qingyuan Guangdong, CN |
| 9610406 | ANSELL (THAILAND) LTD. | THAILAND Krung Thep Maha Nakhon, TH |
| 3026062711 | RMKH GLOVE (CAMBODIA) CO., LTD. | Bavet City Svay Rieng, KH |
| 3043739177 | US Paper Mill LLC | Chillicothe, OH, US |
| 3042765418 | VITAL EDGE INSTRUMENTS LLC | Leesburg, VA, US |
2939935 when referencing this establishment in official correspondence.