FDA.reportPublic FDA data

SAFARI

Primary DI
10723860873269
Brand
SAFARI
Company
Mexpo International Inc.
Model
SFR 87326-B-LTX-PF
Catalog number
SFR 87326-B-LTX-PF
Device description
LATEX EXAMINATION GLOVES POWDER FREE BLACK (SMALL)
Published
2022-02-22
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

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00723860873262PrimaryGS10
10723860873269Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00723860873262007238608732627238608732620723860873262
1072386087326910723860873269

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
779982974
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10723860013320BLOSSOMBM 1355-RD DAMBM 1355-RD DAM2023-06-16
10723860013344BLOSSOMBM 1366-RD DAMBM 1366-RD DAM2023-06-16
10723860013665BLOSSOMBM1366B-RD DAMBM1366B-RD DAM2023-06-16
10723860014556BLOSSOMBM1355B-RD DAMBM1355B-RD DAM2023-06-16
10723860015553BLOSSOMBM 1555-RD DAM BLKBM 1555-RD DAM BLK2023-06-16
10723860015669BLOSSOMBM 1566-RD DAM BLKBM 1566-RD DAM BLK2023-06-16
10723860016550BLOSSOMBM1655-RD DAMBM1655-RD DAM2023-06-16
10723860016666BLOSSOMBM 1666-RD DAMBM 1666-RD DAM2023-06-16
10723860423754BLOSSOMBM 42375-DON-N-PFBM 42375-DON-N-PF2023-06-09
10723860423761BLOSSOMBM 42376-DON-N-PFBM 42376-DON-N-PF2023-06-09
10723860423778BLOSSOMBM 42377-DON-N-PFBM 42377-DON-N-PF2023-06-09
10723860423785BLOSSOMBM 42378-DON-N-PFBM 42378-DON-N-PF2023-06-09
10723860423792BLOSSOMBM 42379-DON-N-PFBM 42379-DON-N-PF2023-06-09
10723860110012BLOSSOMFM-B1001FM-B10012022-03-01
10723860110029BLOSSOMFM-G1002FM-G10022022-03-01
10723860110036BLOSSOMFM-P1003FM-P10032022-03-01
10723860110043BLOSSOMFM-W1004FM-W10042022-03-01
10723860110050BLOSSOMFM-M1005FM-M10052022-03-01
10723860112061BLOSSOMFM-P1206FM-P12062022-03-01
10723860241419THE SEATS FM-B24141TS FM-B241412022-03-01

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Primary DI, Brand, Company table
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D77116100XL0GuardianICP, INC.LYY2026-03-19
D77116100XS0GuardianICP, INC.LYY2026-03-19
40080196762744MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762751MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762775MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
10888277703582MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
00810094090913ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090920ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090937ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090944ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090951ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
D1057115XS9MacTouch Surgimac LLCLYY2025-08-14
D1057115XSCS9MacTouch Surgimac LLCLYY2025-08-14
D1057116S9MacTouch Surgimac LLCLYY2025-08-14
D1057116SCS9MacTouch Surgimac LLCLYY2025-08-14
D1057117M9MacTouch Surgimac LLCLYY2025-08-14
D1057117MCS9MacTouch Surgimac LLCLYY2025-08-14
D1057118L9MacTouch Surgimac LLCLYY2025-08-14
D1057118LCS9MacTouch Surgimac LLCLYY2025-08-14
D1057119XL9MacTouch Surgimac LLCLYY2025-08-14
D1057119XLCS9MacTouch Surgimac LLCLYY2025-08-14
20742061700232KVPKVP International, Inc.LYY2025-08-12
20742061700249KVPKVP International, Inc.LYY2025-08-12
00742061700252KVPKVP International, Inc.LYY2025-08-12
20742061700263KVPKVP International, Inc.LYY2025-08-12
10076490456518TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
20076490001463TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30