FDA.reportPublic FDA data

Intercept

Primary DI
10850018123690
Brand
Intercept
Company
P H & S PRODUCTS LLC
Model
1LICNG-XS
Device description
7mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder Free, Textured Finger Tips, Steel Blue, Size X-Small
Published
2020-08-01
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091147000POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)Smart Glove Corp. Sdn Bhd2009-07-27LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850018123690PackageGS110Not in Commercial Distribution
00850018123693PrimaryGS10
00850018123709Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001812369010850018123690
00850018123693008500181236938500181236930850018123693
00850018123709008500181237098500181237090850018123709

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
968344643
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06