FDA Device Registration & Listing · INDIANAPOLIS, IN, US · Registration 1833700
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2023-06-01 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-06-01 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2023-06-01 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-13 |
| PWU | Clean-Up Kit | General Hospital | Class 1 | 880.6890 | 2020-03-17 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2020-01-24 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2026-03-31 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-13 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-12 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2022-11-22 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-02-19 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-12 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2020-01-24 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-13 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2024-03-21 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2024-03-21 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-12 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-15 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-12 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2024-02-15 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-02-15 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2024-02-15 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-03-31 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2026-03-31 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2026-03-31 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2026-03-31 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-13 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4760 | 2022-11-22 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2022-11-22 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-02-13 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-24 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2020-01-24 |
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 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0010-2013 | C.R. Bard, Inc., Urological Division | 2 | 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder. |
| Z-0025-2020 | AURIS HEALTH INC | 2 | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 |
| 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 |
| 3013681444 | ANREL DISTRIBUTION LLC | Jackson, NJ, US |
| 3036774599 | PT NEWPOINT TECHNOLOGY | Simalungun Sumatera Utara, ID |
1833700 when referencing this establishment in official correspondence.