K Number
K102559
Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Date Cleared
2010-10-21

(44 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow), is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
More Information

Not Found

No
The device is a simple examination glove and the summary contains no mention of AI or ML.

No
This device, a glove, is intended to prevent contamination, not to provide therapy or treatment for a disease or condition.

No
The device is described as examination gloves used to prevent contamination, which is a protective barrier, not a diagnostic tool.

No

The device is a physical glove, not software. The description clearly states it is a disposable device worn on the hand or finger.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is clearly stated as a barrier device worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
  • Device Description: The description focuses on the material (vinyl), color, and adherence to a standard for examination gloves (ASTM D 5250-06). This is consistent with a medical device for examination, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
  • Performance Studies: The performance studies focus on physical properties like waterleak tests and adherence to standards for gloves, not diagnostic accuracy metrics.

IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

N/A

Intended Use / Indications for Use

Powder Free Vinyl Patient Examination Gloves, Colored (Yellow), is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Product codes

LYZ

Device Description

Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner / medical purposes

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Nonclinical testing: Powder free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10. Clinical data: Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

Key Metrics

Not Found

Predicate Device(s)

K051156

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

0

510(K) Summary

K102669

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________

Premarket Notification [510(k)] Summary

[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :

Submitter's name :TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD.
Submitter's address :NORTH ROAD, LUANNAN COUNTY , TANGSHAN CITY ,
HEBEI PROVINCE, 063500, CHINA
Phone number :(86) 315-4169201
Fax number :(86) 315-4169311
Name of contact person:Mr. Fred Zhang
Date the summary was prepared:Aug. 10th, 2010

[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Device Name:Powder free Vinyl Patient Examination Gloves, Colored (Yellow)
Proprietary/Trade name:Powder Free Vinyl Patient Examination Gloves
Common Name:Patient examination glove
Classification Name:Patient examination glove
Device Classification:I
Regulation Number:21 CFR 880.6250
Panel:General Hospital (80)
Product Code:LYZ

(a)(3)). An identification of the legally marketed device to which your firm is claiming substantial equivalence .

Class I* powder free vinyl patient examination gloves , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06.

Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .

[(a)(4)] A description of the device

Device Description : Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

f the device

1

K102559

[(a)(5)] The summary describes the intended use of the device

Device Intended Use: Powder free Vinyl Patient Examination Gloves, Colored (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.

The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

CharacteristicsStandardDevice performance
DimensionASTM standard D 5250-06Meets
Physical PropertiesASTM standard D 5250-06Meets
Freedom from pinholes21 CFR 800.20Meets
Powder ResidualASTM standard D 5250-06Meets
and D6124-01