Powder free 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

powder free vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves," not an AI-powered medical device study. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.

However, I can extract the relevant information about the device's performance based on the provided document:

Acceptance Criteria and Device Performance

Characteristics	Standard	Reported Device Performance
Dimension	ASTM standard D 5250-00e4	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00e4	<2mg/glove (Meets)
Biocompatibility	Primary Skin Irritation in rabbits	Passes (Not a Primary Skin Irritation)
	Dermal sensitization in the guinea pig	Passes (Not a Dermal sensitization)

Study Details (where applicable based on the provided document):

Sample size used for the test set and the data provenance: Not applicable. The document discusses device characteristics and meeting standards, not a test set in the context of an AI study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant to this product. The 'ground truth' here refers to whether the glove met the specified standards.
Adjudication method for the test set: Not applicable. The "adjudication method" is not relevant to the described testing of physical characteristics and biocompatibility.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (gloves), not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (gloves), not an AI system.
The type of ground truth used: The 'ground truth' for the device was defined by established regulatory standards and test methods, such as ASTM D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, and ISO10993-10 for physical properties and biocompatibility.
The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Further Explanation of the Study:

The document describes a premarket notification (510(k)) where the manufacturer seeks to demonstrate that their "Powder Free Vinyl Patient Examination Gloves" are substantially equivalent to a legally marketed predicate device. This is achieved by showing that the new device meets established industry standards and FDA regulations for physical properties, freedom from pinholes, powder residual, and biocompatibility.

The "study" in this context refers to the non-clinical testing performed to demonstrate compliance with these standards. The testing methods mentioned are:

ASTM standard D 5250-00e4: For Dimension, Physical Properties, and Powder Residual.
21 CFR 800.20: For Freedom from pinholes (waterleak test).
ISO10993-10 / Primary Skin Irritation in rabbits: For Biocompatibility.
ISO10993-10 / Dermal sensitization in the guinea pig: For Biocompatibility.

The conclusions from these non-clinical tests were that the Blue Sail (Brand) Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements as detailed in the table above. Clinical data was explicitly stated as "not needed for gloves or for most devices cleared by the 510(k) process" for this type of device.

Summary

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NOV 1 3 2003

C Summary

"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: K032781." (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 Blue Sail Chemical Co.,Ltd
Submitter's address :	Qilu Chemical Industrial Area, Zibo City, Shandong Province ,255414, P.R.China
Phone number :	(86)533-7486199
Fax number :	(86)533-7481177
Name of contact person:	Liu Wenjing
Date the summary was prepared:	2 September 2003

[(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,white(non-colored)
Proprietary/Trade name:	Blue Sail (Brand) Powder Free Vinyl Patient Examination GlovesOther 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:	LZA

[(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 , white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.

Predicate device : synthetic powder-free (white ) vinyl patient examination glove, Shijiazhuang Great Eagle Plastics Products Co., Ltd. K000071 .

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

Device Description : powder free vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

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

Device Intended Use: powder free vinyl patient examination glove, white (nonis a disposable device intended for medical purposes that is worn on the examiner's colored) 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.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 5250-00e4	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00e4	Meets
Biocompatability	Primary Skin Irritation in rabbits	<2mg/glovePassesNot a Primary Skin Irritation
	Dermal sensitization in the guinea pig	PassesNot a Dermal sensitization

[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Powder free vinyl patient examination gloves ,white(non-colored) meet requirements per ASTM D5250-0064, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.

[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

[(b)(3)] The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).

It can be concluded that the Blue Sail (Brand) Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Zibo Blue Sail Chemical Corporation Limited C/O Ms. Yuhong Chen Tuv Rheinland Beijing Office Rm 707, AVIC Bldg, No. 2 No. 2 Dong San Huan Nan Road Chaoyang District, Beijing, 100022, P.R. CHINA

Re: K032781

Trade/Device Name: Blue Sail (Brand) Powder Free Vinyl Patient Examination Gloves, White (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 3, 2003 Received: September 8, 2003

Dear Ms. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Yuhong

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Cus

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

Applicant: Zibo Blue Sail Chemical Co.,Ltd.

510(k) Number (if known): * Blue Sail (Brand Device Name: Powder Free Vinyl Patient Examination Gloves, White(non-colored)

Indications For Use:

Powder free 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.

Susanna F. Baru D

Division of Anesthesiology, General Hospital, Infection Control, De

510(k) Number:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 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.