FDA.reportPublic FDA data

Intercept

Primary DI
10850018123737
Brand
Intercept
Company
P H & S PRODUCTS LLC
Model
1LICNG-M
Device description
7mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder Free, Textured Finger Tips, Steel Blue, Size Medium
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
10850018123737PackageGS110Not in Commercial Distribution
00850018123730PrimaryGS10
00850018123747Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001812373710850018123737
00850018123730008500181237308500181237300850018123730
00850018123747008500181237478500181237470850018123747

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
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
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01