K Number
K070008
Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES
Date Cleared
2007-02-08

(36 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered vinyl 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.
Device Description
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
More Information

Not Found

No
The device is a simple physical barrier (gloves) and the description contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.

No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.

No
Explanation: The device is a glove, which is a barrier to prevent contamination, not a tool for diagnosing medical conditions.

No

The device is a physical product (gloves) and the summary describes physical properties and testing, not software functionality.

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

Here's why:

  • Intended Use: The intended use is to be 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 a sample taken from the body.
  • Device Description: The description is for a physical glove, not a reagent, instrument, or kit used for testing biological samples.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.
  • Regulatory Classification: Patient examination gloves are typically classified under different regulatory categories than IVDs (e.g., Class I or II medical devices for general use). The predicate device K032907 is also for patient examination gloves, further supporting this.

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

Powdered vinyl 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.

Product codes

LYZ

Device Description

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

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

Not Found

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: Powdered vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-006, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.
Clinical testing: Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

Key Metrics

Not Found

Predicate Device(s)

K032907

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

Ko70008

Summary

8 2007 FEB

"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: ______________________________________________________________________________________________________________________________________________ ." (applicant leave blank)

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 :ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO., LTD
Submitter's address :Zhangdian District , SCIENCE/TEC. PARK OF
ZIBO , SHANGDONG PROVINCE, 255087, P. R. CHINA
Phone number :(86)-533-3819127
Fax number :(86)-533-3818127
Name of contact person:Mr. NIE Jian
Date the summary was prepared:Dec. 28,2006

((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: | Powdered Vinyl Patient Examination Gloves,
Clear (Non-colored) | |
|-------------------------|-----------------------------------------------------------------------------|--|
| Proprietary/Trade name: | Powdered Vinyl Patient Examination Gloves
Other clients private labeling | |
| 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 1* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00t4

Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.

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

1

Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

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

Device Intended Use: powdered vinyl patient examination glove, Clear(non-colored) 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 powdered vinyl patient examination gloves, Clear (non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

CharacteristicsStandardDevice performance
DimensionASTM standard D 5250-00e4Meets
Physical PropertiesASTM standard D 5250-00e4Meets
Freedom from pinholes21 CFR 800.20Meets
Powder AmountASTM standard D 5250-00e4