K Number
K092956
Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Date Cleared
2009-12-04

(70 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl patient examination glove is a non-sterile 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
More Information

Not Found

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

No.
The gloves are for preventing contamination between patient and examiner, not for treating a disease or condition.

No

Explanation: The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnosis or analysis of a patient's condition.

No

The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove" and mentions physical standards like ASTM D 5250-06e1.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
  • Device Description: The description focuses on the material (vinyl), form (powder-free), and compliance with standards related to gloves (ASTM D 5250-06e1).
  • Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's condition.
  • No Mention of IVD-Specific Regulations: The standards mentioned (ASTM D 5250, ASTM D6124, 21 CFR 800.20, ISO 10993-10) are relevant to medical devices, but not specifically to IVDs.

IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This glove does not fit that definition.

N/A

Intended Use / Indications for Use

"Powder free vinyl patient examination glove is a non-sterile 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 (comma separated list FDA assigned to the subject device)

LYZ

Device Description

"powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06e1."

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

"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 5250-06 el.Meets
Physical PropertiesASTM standard D 5250-06 el.Meets
Freedom from pinholes21 CFR 800.20Meets
Powder ResidualASTM standard D 5250-06 el
and D6124-06Meets

§ 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

Section C 510(k) Summary (21 CFR 807.92)

510(k) Summary

DEC - 4 2009

"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: K092956 " (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 :Shandong Aobo Medical Co.,Ltd.
Submitter's address :Xingshan Laboder Road,Economic Development
Zone of Zichuan,Zibo City, Shandong
Province, 255100, China.
Phone number :86-533-2557777
Fax number :86-533-6023666
Name of contact person:Mr.He lin
Date the summary was prepared:Sep 10.2009

((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,
Clear(non-colored) |
|-------------------------|--------------------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves
Other clients private labeling |
| Common Name: | Exam gloves |
| 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

Section C

1

5/0(k): K092956

the requirements of ASTM standard D 5250-06e1.

Predicate device: FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .

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

Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

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

Device Intended Use: powder free 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 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 5250-06 el.Meets
Physical PropertiesASTM standard D 5250-06 el.Meets
Freedom from pinholes21 CFR 800.20Meets
Powder ResidualASTM standard D 5250-06 el
and D6124-06Meets