Raxwell RX PRO Black Nitrile Glove, 4.5 mil100/box · 10 boxes/case

Raxwell Industries · RX PRO Black 4.5 mil

Intended use: patient examination
Not made with natural rubber latex

Raxwell black nitrile gloves, 4.5 mil: dispenser box with a black glove

Raxwell RX PRO black nitrile gloves, 4.5 mil: 900-glove case with ten 90-count dispenser boxes and a black glove (manufacturer image)

Manufacturer: Raxwell Industries
Brand or line: RX PRO Black 4.5 mil
Country of manufacture: Not stated by the manufacturer
FDA 510(k): Provided with your quote
Product code: LZA
Manufacturer page: raxwellusa.com

Specifications

Specifications for Raxwell RX PRO Black Nitrile Glove, 4.5 mil
Attribute	Value	Basis
Thickness, weight and length
Thickness — location not stated	4.5 mil (0.11 mm) Nominal · measurement location not stated by the manufacturer	Nominal · measurement location not stated by the manufacturer
Weight per glove	Not stated by the manufacturer
Length	230 mm Minimum · Manufacturer spec	Minimum · Manufacturer spec
Quality and strength
Pinhole AQL	Not stated by the manufacturer FDA minimum for exam gloves: 2.5	FDA minimum for exam gloves: 2.5
Tensile strength	≥ 21 MPa Manufacturer spec	Manufacturer spec
Elongation	Not stated by the manufacturer
Standards stated by the manufacturer	Not stated by the manufacturer
Construction
Texture	Fully textured
Cuff	Not stated by the manufacturer
Color	Black
Sterility	Not stated by the manufacturer
Testing
Chemotherapy testing	Stated by the manufacturer Manufacturer statement	Manufacturer statement
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.

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	Case dimensions
XS	RXI20242-B	100	10	1,000
S	RXI20223-B	100	10	1,000	12.2 × 9.45 × 9.45 in
M	RXI20224-B	100	10	1,000	12.2 × 9.45 × 9.45 in
L	RXI20225-B	100	10	1,000	12.2 × 9.45 × 9.45 in
XL	RXI20226-B	100	10	1,000	12.2 × 9.45 × 9.45 in
XXL	RXI20241-B	100	10	1,000	12.2 × 9.45 × 9.45 in

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 K232008, Disposable Medical Examination Nitrile Gloves (black), submitter Raxwell Industries LLC · FDA

fda.gov · rev. Aug 2023

Verify on FDA’s database (opens fda.gov) 510(k) summary K232008, Disposable Medical Examination Nitrile Gloves (black), submitter Raxwell Industries LLC
FDA database record — FDA 510(k) record K232008, Raxwell Industrial, LLC

fda.gov

Verify on FDA’s database (opens fda.gov) FDA 510(k) record K232008, Raxwell Industrial, LLC
Raxwell RX PRO Black Nitrile Gloves 4.5 mil spec sheet · Brand owner’s site

raxwellusa.com

View the brand owner’s copy (opens raxwellusa.com) Raxwell RX PRO Black Nitrile Gloves 4.5 mil spec sheet
Raxwell disposable black nitrile gloves 4.5 mil product page (raxwellusa.com) · Brand owner’s site

raxwellusa.com

View the brand owner’s copy (opens raxwellusa.com) Raxwell disposable black nitrile gloves 4.5 mil product page (raxwellusa.com)
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.

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.