HALYARD PURPLE NITRILE-XTRA Exam Glove, 12 in50/box · 10 boxes/case

O&M Halyard, Inc. (HALYARD) · PURPLE NITRILE-XTRA

Intended use: patient examination
Not made with natural rubber latex
Powder-free
Non-sterile

HALYARD PURPLE NITRILE-XTRA powder-free extended-cuff exam gloves box, size L (manufacturer image)

Manufacturer: O&M Halyard, Inc. (HALYARD)
Brand or line: PURPLE NITRILE-XTRA
Country of manufacture: Not stated by the manufacturer
FDA 510(k): Provided with your quote
Product code: LZA
Intended use: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder: Powder-free
Manufacturer page: products.halyardhealth.com

Specifications

Fingertip 5.9 mil (0.15 mm)
Palm 4.7 mil (0.12 mm)

Thickness by location, this product · numbers match the specification rows · not to scale

Specifications for HALYARD PURPLE NITRILE-XTRA Exam Glove, 12 in
Attribute	Value	Basis
Thickness, weight and length
Thickness — fingertip (point 1 on the drawing)	5.9 mil (0.15 mm) Nominal · Manufacturer spec	Nominal · Manufacturer spec
Thickness — palm (point 2 on the drawing)	4.7 mil (0.12 mm) Nominal · Manufacturer spec	Nominal · Manufacturer spec
Weight per glove	Not stated by the manufacturer
Length	12 in (305 mm) Nominal · Manufacturer spec	Nominal · Manufacturer spec
Quality and strength
Pinhole AQL	2.5 510(k) acceptance criterion, inspection level not stated · FDA minimum for exam gloves: 2.5	510(k) acceptance criterion, inspection level not stated · FDA minimum for exam gloves: 2.5
Tensile strength	Not stated by the manufacturer
Elongation	Not stated by the manufacturer
Standards stated by the manufacturer	ASTM D6978 -05 Manufacturer claim	Manufacturer claim
Construction
Texture	Textured fingertips
Cuff	Not stated by the manufacturer, extended cuff
Color	Purple
Sterility	Non-sterile
Testing
Chemotherapy testing	Tested (listed drugs) ASTM D6978 — tested against the listed drugs only	ASTM D6978 — tested against the listed drugs only
Fentanyl testing	Stated in the FDA record Manufacturer statement	Manufacturer statement
Storage
Shelf life	Not stated by the manufacturer — confirmed on your quote
Storage	Not stated by the manufacturer

Packaging

Pack-out by size.

Scroll sideways to see all columns. The size stays in view.

Pack-out by size
Size	Mfr item no.	Gloves per box	Boxes per case	Gloves per case
XS	55090	50	10	500
S	50601	50	10	500
M	50602	50	10	500
L	50603	50	10	500
XL	50604	50	10	500
XXL	48953	50	10	500

Cases per pallet: We’ll confirm pallet configuration on your quote.

Mixed sizes in one case: not available · Mixed sizes in one order: yes.

Documents

Documents we may share publicly, plus FDA’s own record

Chemotherapy drug list for HALYARD PURPLE NITRILE-XTRA Exam Glove, 12 in · FDA

fda.gov · rev. Jul 2025

Chemotherapy claim: tested against the listed drugs only

Verify on FDA’s database (opens fda.gov) Chemotherapy drug list for HALYARD PURPLE NITRILE-XTRA Exam Glove, 12 in
FDA database record — FDA 510(k) record K160709 (openFDA): earlier HALYARD PURPLE NITRILE XTRA clearance (predicate of K243604)

fda.gov

Verify on FDA’s database (opens fda.gov) FDA 510(k) record K160709 (openFDA): earlier HALYARD PURPLE NITRILE XTRA clearance (predicate of K243604)
FDA database record — FDA 510(k) record K243604

fda.gov

Verify on FDA’s database (opens fda.gov) FDA 510(k) record K243604
HALYARD PURPLE NITRILE exam gloves product page (covers PURPLE NITRILE and PURPLE NITRILE-XTRA) · Manufacturer site

halyardhealth.com

View the manufacturer’s copy (opens halyardhealth.com) HALYARD PURPLE NITRILE exam gloves product page (covers PURPLE NITRILE and PURPLE NITRILE-XTRA)
Spec sheet · Manufacturer site — HALYARD exam gloves quick reference guide (multi-product specification table)

halyardhealth.com

View the manufacturer’s copy (opens halyardhealth.com) HALYARD exam gloves quick reference guide (multi-product specification table)
Product page · Manufacturer site — Halyard eCatalog list of medical exam gloves (product names only render)

products.halyardhealth.com

View the manufacturer’s copy (opens products.halyardhealth.com) Halyard eCatalog list of medical exam gloves (product names only render)
Lot certificate of analysis

Available with your order when the supplier provides a lot certificate

Any other document is available from your representative on request.

Testing and claims

As stated by the manufacturer, in the manufacturer’s scope — with the document each statement comes from.

Chemotherapy drugs (ASTM D6978): Tested for use with chemotherapy drugs per ASTM D6978 (52 drugs, per the manufacturer); see the manufacturer's tested-drug list. Manufacturer caution: minimum breakthrough time with Carmustine was 60 minutes. Per the FDA record (Chemotherapy drug list) (2025-07-31)

How to read this page

Every value on this page is the manufacturer’s own statement or a regulator’s record, with the document named. Where a manufacturer does not state a value, the page says so. Pricing, availability and lead time are confirmed on your written quote.