FDA Device Registration & Listing · Westerville, OH, US · Registration 3007502227
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2024-04-15 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-04-15 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-01-21 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2025-01-21 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-01-21 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2025-02-11 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2025-02-11 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-11 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-02-11 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-04-02 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-06 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-04-06 |
| HOI | Spectacle, Magnifying | Ophthalmic | Class 1 | 886.5840 | 2014-09-24 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-04-02 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2024-03-13 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2024-03-13 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-03-13 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2024-03-13 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2025-02-05 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-02-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-05 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-11 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-01-08 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2020-05-07 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-04-06 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-01-28 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2020-05-12 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-01-21 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2025-01-21 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2025-01-21 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-01-21 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-07-31 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-07-31 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2025-07-31 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-03-13 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-17 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | Class 1 | 886.5850 | 2009-03-19 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-18 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-04-10 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-04-15 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-04-15 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-18 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-02-18 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-05 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-04-06 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-06-19 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-04-15 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-03-13 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-02-06 |
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 |
| 3013681444 | ANREL DISTRIBUTION LLC | Jackson, NJ, US |
3007502227 when referencing this establishment in official correspondence.