Halyard
HALYARD Purple Nitrile-Xtra is a disposable, powder-free nitrile examination glove. Medical examination gloves provide a hand barrier during care when hands may contact body fluids or…
HALYARD Purple Nitrile-Xtra is a disposable, powder-free nitrile examination glove. Medical examination gloves provide a hand barrier during care when hands may contact body fluids or potentially contaminated items, helping protect both wearer and patient as part of infection-control practice.
The filed item is the extra-small Emergency Responder Series configuration. Halyard identifies the product family as made without natural-rubber latex and lists ambidextrous fit and textured fingertips. The manufacturer page’s displayed size example is large, so the XS identity here follows the filed item.
Listed Item
HALYARD* PURPLE NITRILE-XTRA* Powder-Free Exam Gloves, XS, Emergency Responder Series
Glove Construction
Nitrile is a synthetic glove material, and the Purple Nitrile-Xtra page describes a powder-free, non-latex design. Halyard lists texture at the fingertips, placing that surface feature at the parts of the glove used to contact objects. The product is identified as nonsterile examination PPE.
Who Else Makes It
Concentrated in Shandong (18), Guangdong (5), Hebei (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanxi Hongjin Plastic Technology Co., Ltd. | Linfen | Shanxi | Contract manufacturer | 5 |
| YUE Kang Anhui Medical Products Co., Ltd. | Huaibei | Anhui | Contract manufacturer | 5 |
| Opus Gloves Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Better Care Plastic Technology Co., Ltd. | Shenze County | Hebei | Contract manufacturer | 4 |
| Xingyu Medical Tech Co., Ltd. | Weifang | Shandong | Contract manufacturer | 4 |
| Lingshi Hongruida Health Protection Technology Co., Ltd. | Jinzhong | Shanxi | Contract manufacturer | 4 |
| Zhangjiagang Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 3 |
| Zhongnuo Medical Products Co., Ltd. | Tangshan | Hebei | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Showing 12 of 48. All 48 manufacturers in China registered for Medical Glove, Specialty
Record
| Listed by | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | LZC |
| Device type | Medical Glove, Specialty |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K081089 |
| Record published | 2020-09-15 |
| Record revised | 2025-08-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 4, dsp of 50, case of 8, dsp, dsp of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47635 | 300 | In distribution | |
| 48383 | 200 | In distribution | |
| 44620 | 500 | In distribution | |
| 48751 | 200 | In distribution | |
| 50486 | 100 | In distribution | |
| 47373 | 200 | In distribution | |
| 44992 | 50 | In distribution | |
| 48767 | 100 | In distribution | |
| 48129 | 300 | In distribution | |
| 48036 | 300 | In distribution | |
| 55097 | 150 | In distribution | |
| 47638 | 250 | In distribution | |
| 48385 | 200 | In distribution | |
| 47342 | 250 | In distribution | |
| 47374 | 200 | In distribution | |
| 41659 | 250 | In distribution | |
| 48366 | 50 | In distribution | |
| 14259 | 2 | In distribution | |
| 43934 | 300 | In distribution | |
| 47339 | 250 | In distribution | |
| 52818 | 250 | In distribution | |
| 50239 | 250 | In distribution | |
| 39505 | 50 | In distribution | |
| 43935 | 300 | In distribution | |
| 50853 | 500 | In distribution | |
| 47453 | 100 | In distribution | |
| 14261 | 2 | In distribution | |
| 47341 | 250 | In distribution | |
| 50241 | 250 | In distribution | |
| 43932 | 300 | In distribution | |
| 33023 | 2 | In distribution | |
| 48387 | 180 | In distribution | |
| 48130 | 300 | In distribution | |
| 50602 | 50 | In distribution | |
| 52101 | In distribution | ||
| 41658 | 250 | In distribution | |
| 52820 | 230 | In distribution | |
| 48035 | 300 | In distribution | |
| 52103 | In distribution | ||
| 55081 | 100 | In distribution | |
| 55082 | 100 | In distribution | |
| 48384 | 200 | In distribution | |
| 48953 | 50 | In distribution | |
| 53141 | 100 | In distribution | |
| 48422 | 100 | In distribution | |
| 48037 | 250 | In distribution | |
| 44995 | 50 | In distribution | |
| 47634 | 300 | In distribution | |
| 48386 | 200 | In distribution | |
| 47376 | 200 | In distribution | |
| 48033 | 300 | In distribution | |
| 44621 | 500 | In distribution | |
| 50070 | 250 | In distribution | |
| 55080 | 100 | In distribution | |
| 48131 | 300 | In distribution | |
| 50601 | 50 | In distribution | |
| 47456 | 100 | In distribution | |
| 41662 | 230 | In distribution | |
| 44994 | 50 | In distribution | |
| 44993 | 50 | In distribution | |
| 48421 | 100 | In distribution | |
| 50495 | 2 | In distribution | |
| 52816 | 250 | In distribution | |
| 55084 | 90 | In distribution | |
| 50482 | 50 | In distribution | |
| 47377 | 180 | In distribution | |
| 48034 | 300 | In distribution | |
| 50487 | 100 | In distribution | |
| 14262 | 2 | In distribution | |
| 52817 | 250 | In distribution | |
| 39507 | 50 | In distribution | |
| 50242 | 230 | In distribution | |
| 14263 | 2 | In distribution | |
| 50490 | 90 | In distribution | |
| 53139 | 100 | In distribution | |
| 39506 | 50 | In distribution | |
| 47343 | 230 | In distribution | |
| 55095 | 150 | In distribution | |
| 55091 | 2 | In distribution | |
| 39504 | 50 | In distribution | |
| 47636 | 300 | In distribution | |
| 47340 | 250 | In distribution | |
| 48367 | 50 | In distribution | |
| 55090 | 50 | In distribution | |
| 50496 | 2 | In distribution | |
| 55083 | 100 | In distribution | |
| 14260 | 2 | In distribution | |
| 47455 | 100 | In distribution | |
| 50604 | 50 | In distribution | |
| 55093 | 2 | In distribution | |
| 55092 | 2 | In distribution | |
| 47452 | 100 | In distribution | |
| 53138 | 100 | In distribution | |
| 50707 | 200 | In distribution | |
| 48750 | 200 | In distribution | |
| 41660 | 250 | In distribution | |
| 48368 | 50 | In distribution | |
| 53137 | 100 | In distribution | |
| 41657 | 250 | In distribution | |
| 47454 | 100 | In distribution | |
| 47637 | 300 | In distribution | |
| 50603 | 50 | In distribution | |
| 33022 | 2 | In distribution | |
| 48128 | 300 | In distribution | |
| 48799 | 100 | In distribution | |
| 50488 | 100 | In distribution | |
| 52819 | 250 | In distribution | |
| 43936 | 250 | In distribution | |
| 53140 | 100 | In distribution | |
| 55096 | 150 | In distribution | |
| 43933 | 300 | In distribution | |
| 52102 | In distribution | ||
| 47375 | 200 | In distribution | |
| 39508 | 50 | In distribution | |
| 50706 | 200 | In distribution | |
| 48132 | 250 | In distribution | |
| 50489 | 100 | In distribution | |
| 50708 | 200 | In distribution | |
| 48770 | 90 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Europapa | Europapa Handels GmbH | 40 |
| Tronex International, Inc. | Tronex International, Inc. | 37 |
| PremierPro | Prestige Ameritech | 37 |
| Medicom AssureTouch | AMD Medicom Inc. | 29 |
| Ocean Pacific | AMD Medicom Inc. | 25 |
| MediChoice | Owens & Minor Distribution, Inc. | 24 |
| FreeStyle | Hourglass International Inc | 22 |
| Novaplus | Cardinal Health 200, LLC | 21 |
| Scion | Hourglass International Inc | 20 |
| Cardinal Health | Cardinal Health 200, LLC | 18 |
| Flexal | Cardinal Health 200, LLC | 18 |
| Ammex Professional | Ammex Corporation | 18 |
Showing 12 of 174. All products under Medical Glove, Specialty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191230 | 2019-11-08 |
| K183132 | 2019-02-05 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-04-13 | Class II | Under Investigation by firm | Nitrile Exam Glove failed to meet specifications chemical permeation performance. | 452,500 units |
| 2021-09-27 | Class II | Component design/selection | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing. | 2,928 cases (5,856,000 gloves) |
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.