FDA Device Registration & Listing · Pleasant Prairie, WI, US · Registration 3002661124
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2013-11-14 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2016-11-23 |
| EWD | Protector, Hearing (Insert) | Unknown | Class U | N/A | 2018-11-14 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-10-13 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2013-11-14 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2020-11-19 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2019-10-17 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-10-17 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-07-19 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-10-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-12-17 |
| EWE | Protector, Hearing (Circumaural) | Unknown | Class U | N/A | 2018-11-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2017-12-18 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-04-23 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-04-23 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2025-04-23 |
| LRR | First Aid Kit With Drug | Unknown | Class N | N/A | 2018-11-09 |
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | Class 1 | 878.4014 | 2023-02-02 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2019-02-19 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2021-04-08 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-12-13 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-08-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2018-11-14 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2018-11-14 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-03-24 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2013-11-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2013-11-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2018-12-12 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2021-11-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-09-04 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2019-09-04 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2019-09-04 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2022-12-22 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-12-22 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2013-11-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2013-11-14 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K894452 | Kerala Rubber & Reclaims, Ltd. | KRR GLOVE, PATIENT EXAMINATION GLOVES | 1989-08-09 |
| K891323 | Li Wah-Hong Kong, Inc. | LI WAH LATEX EXAMINATION GLOVES | 1989-08-31 |
| K891418 | C & K Mfg. & Sales Co. | LATEX EXAMINATION GLOVES, STYLE 510 LX | 1989-06-22 |
| K994255 | Pt. Maja Agung Latexindo | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE | 2000-02-07 |
| K892946 | Yeou-Fwu Rubber Industrial Co., Ltd. | STERILE PATIENT EXAMINATION GLOVES | 1989-08-10 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3017940518 | STAR INVESTMENT AND TRADE JOINT STOCK COMPANY | Bac Ninh, VN |
| 1000266564 | SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. | Hat Yai Songkhla, TH |
| 8040653 | ARISTA LATINDO INDUSTRIAL, LTD. P.T. | JAKARTA BARAT, ID |
| 3019769825 | HARTALEGA NGC SDN. BHD. (LOT 39496) | Sepang Selangor, MY |
| 8040818 | SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. | MUANG Rayong, TH |
3002661124 when referencing this establishment in official correspondence.