Nulife
Nulife is the trade name for sterile, powder-free latex surgical gloves made from natural rubber. The filing describes them as intended for operating-room personnel to protect a surgical…
Nulife is the trade name for sterile, powder-free latex surgical gloves made from natural rubber. The filing describes them as intended for operating-room personnel to protect a surgical wound from contamination.
The source lists glove sizes from 5.5 through 9 and reports testing against the cited rubber surgical glove specification. This description is limited to the named glove product and its stated use.
Listed Item
Elbow Length gynaecology gloves are sterile and anatomically shaped medical gloves with the thumb positioned towards the palmer surface of the index finger rather than lying flat with length till elbow. These gloves are powder-free. The Elbow length gynaecology gloves are intended for use various gynecological procedures.
Product Details
The summary identifies the device as a sterile latex surgical glove and provides the available size range. It describes the gloves as powder free and intended for surgical personnel.
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (2), Guangxi (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Suzhou Colour-way New Material Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Shanghai Motex Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
| Motex Healthcare (Anhui) Co., Ltd. | Guangde City, Xuancheng | Anhui | Manufacturer | 4 |
| Shanghai Jinxiang Latex Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Guilin HBM Health Protections, Inc. | Guilin | Guangxi | Manufacturer | 2 |
| Puyang Linshi Medical Supplies Co., Ltd. | Puyang | Henan | Contract manufacturer | 2 |
| Guilin Huada Biotechnology Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 1 |
Record
| Listed by | MRK Healthcare Pvt.ltd, India |
|---|---|
| FDA product code | KGO |
| Device type | Surgeon’S Gloves |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4460 |
| Establishment | Manufacturer |
| 510(k) | K210969 |
| Record published | 2023-06-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ultra Gloves Beadless Size – 9.0 | 9.0 | In distribution |
| Elbow length Gynaecology gloves – 7.5 | 7.5 | In distribution |
| Latex Surgical Gloves – Size 6.5 | 6.5 | In distribution |
| Latex Surgical Gloves – Size 7.0 | 7.0 | In distribution |
| Ultra Gloves Beadless Size – 5.5 | 5.5 | In distribution |
| Ultra Gloves Beadless Size – 6.0 | 6.0 | In distribution |
| Latex Surgical Gloves – Size 7.5 | 7.5 | In distribution |
| Ultra Gloves Beadless Size – 8.0 | 8.0 | In distribution |
| Latex Surgical Gloves – Size 8.0 | 8.0 | In distribution |
| Latex Surgical Gloves – Size 6.0 | 6.0 | In distribution |
| Latex Surgical Gloves – Size 5.5 | 5.5 | In distribution |
| Elbow length Gynaecology gloves – 6.5 | 6.5 | In distribution |
| Ultra Gloves Beadless Size – 7.0 | 7.0 | In distribution |
| Ultra Gloves Beadless Size – 7.5 | 7.5 | In distribution |
| Elbow length Gynaecology gloves – 8.5 | 8.5 | In distribution |
| Latex Surgical Gloves – Size 9.0 | 9.0 | In distribution |
| Latex Surgical Gloves – Size 8.5 | 8.5 | In distribution |
| Ultra Gloves Beadless Size – 8.5 | 8.5 | In distribution |
| Ultra Gloves Beadless Size – 6.5 | 6.5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MocareHealth | Motex Healthcare (Anhui) Co., Ltd. | 398 |
| Biogel | Bosma Enterprises | 149 |
| Protexis | Cardinal Health 200, LLC | 141 |
| Medline | Medline Industries, Inc. | 130 |
| Gammex | Ansell Healthcare Product | 126 |
| Medline Industries, Inc. | Medline Industries, Inc. | 118 |
| McKesson | Mckesson Medical-Surgical Inc. | 112 |
| Novaplus | Ansell Healthcare Product | 85 |
| PremierPro Surgeons Glove | Prestige Ameritech | 78 |
| Gammex | Bosma Enterprises | 63 |
| Protexis | Bosma Enterprises | 63 |
| Encore | Ansell Healthcare Product | 60 |
Showing 12 of 106. All products under Surgeon’S Gloves
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210969 | 2021-11-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.