FDA.reportPublic FDA data

PROOF

Primary DI
D8328004C1XL0
Brand
PROOF
Company
PLASDENT CORPORATION
Model
8004C-1XL
Catalog number
8004C-1XL
Device description
Premium Barrier Gown, XL, White
Published
2022-03-25
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
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8328004C1XL1PrimaryHIBCC0
D8328004C1XL0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190377184
Device count
10
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D832BEE0001PlasdentBEE-000BEE-0002026-05-06
D832BEE0011PlasdentBEE-001BEE-0012026-05-06
D832BEE0021PlasdentBEE-002BEE-0022026-05-06
D832906CDG20Plasdent906CDG2906CDG22026-05-01
D832906CDG30Plasdent906CDG3906CDG32026-05-01
D832BLT1011PlasdentBLT-101BLT-1012026-05-01
D832BLT2001PlasdentBLT-200BLT-2002026-05-01
D832BLT2011PlasdentBLT-201BLT-2012026-05-01
D832BLT3001PlasdentBLT-300BLT-3002026-05-01
D832BLT3011PlasdentBLT-301BLT-3012026-05-01
D832BLT3021PlasdentBLT-302BLT-3022026-05-01
D832BLT4181PlasdentBLT-418BLT-4182026-05-01
D832BLT4201PlasdentBLT-420BLT-4202026-05-01
D832BLT4211PlasdentBLT-421BLT-4212026-05-01
D832BLT4221PlasdentBLT-422BLT-4222026-05-01
D832BLT4231PlasdentBLT-423BLT-4232026-05-01
D832BLT4251PlasdentBLT-425BLT-4252026-05-01
D832BLT4271PlasdentBLT-427BLT-4272026-05-01
D832BLT5221PlasdentBLT-522BLT-5222026-05-01
D832BLT522B1PlasdentBLT-522BBLT-522B2026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10198956099128CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101746CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101401CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956101906CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956089303CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-22
10197106988251CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-19
10198956089143CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-14
10197106988176CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-13
10197106824832CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106860120CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106873113CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-18
10197106861936CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106868249CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106779781CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106810477CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106835029CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-19
10197106835128CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-18
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106746011CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13