FDA.reportPublic FDA data

Intercept Free

Primary DI
00150020014607
Brand
Intercept Free
Company
P H & S PRODUCTS LLC
Model
1LICFNG-L
Device description
Nitrile Two-Toned White/Green,Powder Free,Exam Grade Glove,Tested for use with Fentanyl,Heroin and Gastric Acid Size L
Published
2022-05-23
Public version status
New
Distribution status
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
QDOFentanyl and other opioid protection glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220375000Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)Summit Glove, Inc.2022-04-13LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00150020014607PackageGS11000In Commercial Distribution
00850018123389PreviousGS10
00850020014606PrimaryGS10
00850020014613Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00150020014607001500200146071500200146070150020014607
00850018123389008500181233898500181233890850018123389
00850020014606008500200146068500200146060850020014606
00850020014613008500200146138500200146130850020014613

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)868-2239tcalkins@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
false
Serial number
false
Manufacturing date on label
false
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
20680651500674HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500681HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500698HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500711HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502395HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502401HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502418HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502425HalyardO&M HALYARD, INC.QDO2026-06-04
10810141933740VIVIT SupplyVivit Supply LLCQDO2026-02-03
10810141933757VIVIT SupplyVivit Supply LLCQDO2026-02-03
10810141933764VIVIT SupplyVivit Supply LLCQDO2026-02-03
10810141933771VIVIT SupplyVivit Supply LLCQDO2026-02-03
10810141933788VIVIT SupplyVivit Supply LLCQDO2026-02-03
10076490788657MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788664MICROFLEX Ansell Healthcare ProductQDO2025-08-05
10076490788671MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788688MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788695MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490708495KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490714397KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490716568KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490723740KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490737334KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490711426KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490735903KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490737518KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490744004KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490750999KIMTECHAnsell Healthcare ProductQDO2025-07-03