HALYARD BLACK-FIRE Nitrile Exam Glove, Black/Orange, 9.5 in150/box (XL 140) · 10 boxes/case

O&M Halyard, Inc. (HALYARD) · BLACK-FIRE

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

HALYARD BLACK-FIRE powder-free nitrile exam gloves box, size L, REF 44758, 150 count (manufacturer image)

Manufacturer: O&M Halyard, Inc. (HALYARD)
Brand or line: BLACK-FIRE
Country of manufacture: Not stated by the manufacturer
FDA 510(k): K153708 View FDA’s record (opens fda.gov)
Product code: LZA
Intended use: Disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner
Powder: Powder-free
Manufacturer page: halyardhealth.com

Specifications

Fingertip 5.5 mil (0.14 mm)
Palm 3.9 mil (0.10 mm)
Cuff 3.5 mil (0.09 mm)

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

Specifications for HALYARD BLACK-FIRE Nitrile Exam Glove, Black/Orange, 9.5 in
Attribute	Value	Basis
Thickness, weight and length
Thickness — fingertip (point 1 on the drawing)	5.5 mil (0.14 mm) Nominal · Manufacturer spec	Nominal · Manufacturer spec
Thickness — palm (point 2 on the drawing)	3.9 mil (0.10 mm) Nominal · Manufacturer spec	Nominal · Manufacturer spec
Thickness — cuff (point 3 on the drawing)	3.5 mil (0.09 mm) Nominal · Manufacturer spec	Nominal · Manufacturer spec
Weight per glove	Not stated by the manufacturer
Length	242 mm Average · Manufacturer spec	Average · Manufacturer spec
Quality and strength
Pinhole AQL	1.0 510(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	Not stated by the manufacturer
Construction
Texture	Textured fingertips
Cuff	Not stated by the manufacturer
Color	Black exterior, high-visibility orange inner layer
Sterility	Non-sterile
Testing
Chemotherapy testing	Not stated by the manufacturer
Fentanyl testing	Stated by the manufacturer 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. Some sizes differ.

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	44755	150	10	1,500
S	44756	150	10	1,500
M	44757	150	10	1,500
L	44758	150	10	1,500
XL Differs : 1,400 gloves per case	44759	140	10	1,400

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

510(k) summary K153708, Halyard Black-Orange Powder-Free Nitrile Exam Glove · FDA

fda.gov · rev. Feb 2016

Verify on FDA’s database (opens fda.gov) 510(k) summary K153708, Halyard Black-Orange Powder-Free Nitrile Exam Glove
FDA database record — FDA 510(k) database record K153708

fda.gov

Verify on FDA’s database (opens fda.gov) FDA 510(k) database record K153708
Spec sheet · Manufacturer site — BLACK-FIRE powder-free nitrile exam gloves sell sheet with specification table

halyardhealth.com

View the manufacturer’s copy (opens halyardhealth.com) BLACK-FIRE powder-free nitrile exam gloves sell sheet with specification table
HALYARD BLACK-FIRE nitrile exam gloves product page · Manufacturer site

halyardhealth.com

View the manufacturer’s copy (opens halyardhealth.com) HALYARD BLACK-FIRE nitrile exam gloves product page
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.

Fda 510k: Manufacturer's FDA 510(k): K153708 - patient examination glove (21 CFR 880.6250). Per the FDA record (FDA database record)
Powder: Powder-free. Per the manufacturer's spec sheet
Thickness: Middle finger 0.14 mm (5.5 mil); palm 0.10 mm (3.9 mil); cuff 0.09 mm (3.5 mil). Manufacturer target values, Halyard sell sheet C171938. Per the manufacturer's spec sheet

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.