FDA.reportPublic FDA data

Intercept Free

Primary DI
00850020014569
Brand
Intercept Free
Company
P H & S PRODUCTS LLC
Model
1LICFNG-S
Device description
Nitrile Two-Toned White/Green,Powder Free,Exam Grade Glove,Tested for use with Fentanyl,Heroin and Gastric Acid Size S
Published
2022-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00150020014560PackageGS11000In Commercial Distribution
00850018123341PreviousGS10
00850020014569PrimaryGS10
00850020014576Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00150020014560001500200145601500200145600150020014560
00850018123341008500181233418500181233410850018123341
00850020014569008500200145698500200145690850020014569
00850020014576008500200145768500200145760850020014576

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(330)868-2239tcalkins@phs-products.com

Regulatory Flags#

DUNS number
968344643
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018123020ResQ-Grip79720PF-BKGR2020-08-01
00850018123044ResQ-Grip79730PF-BKGR2020-08-01
00850018123068ResQ-Grip79740PF-BKGR2020-08-01
00850018123082ResQ-Grip79750PF-BKGR2020-08-01
00850018123105ResQ-Grip79760PF-BKGR2020-08-01
00850018123129ResQ-Grip79770PF-BKGR2020-08-01
00850018123464Vital Shield SCFVSN7SC-S2020-08-01
00850018123488Vital Shield SCFVSN7SC-M2020-08-01
00850018123501Vital Shield SCFVSN7SC-L2020-08-01
00850018123525Vital Shield SCFVSN7SC-XL2020-08-01
00850018123549Vital Shield SCFVSN7SC-2XL2020-08-01
00850018123563Vital Shield SCFVSN7SC-3XL2020-08-01
00850018123587Flextreme1LFTNG-S2020-08-01
00850018123600Flextreme1LFTNG-M2020-08-01
00850018123624Flextreme1LFTNG-L2020-08-01
00850018123648Flextreme1LFTNG-XL2020-08-01
00850018123662Flextreme1LFTNG-2XL2020-08-01
00850018123686Flextreme1LFTNG-3XL2020-08-01
00850020014323ResQ-Grip79720PF-BKGR2020-08-01
00850020014347ResQ-Grip79730PF-BKGR2020-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502401HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502425HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04