Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.

Device Description

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves":

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Characteristic	Acceptance Criteria (Predicate or ASTM Standard)	Reported Device Performance (Subject Device)	Result of Comparison
Dimensions:
-- Length	Meets ASTM D5250-06 (Reapproved 2011) ≥230mm min.	230mm min. for all sizes	Substantially equivalent
-- Width (Small)	Meets ASTM D5250-06 (Reapproved 2011) 80-90 mm	80-85 mm	Substantially equivalent
-- Width (Medium)	Meets ASTM D5250-06 (Reapproved 2011) 90-100 mm	95-97 mm	Substantially equivalent
-- Width (Large)	Meets ASTM D5250-06 (Reapproved 2011) 100-110 mm	102-108 mm	Substantially equivalent
-- Width (X large)	Meets ASTM D5250-06 (Reapproved 2011) 110-120 mm	114-118 mm	Substantially equivalent
Thickness:
-- Finger	0.05mm min.	0.05mm min.	Substantially equivalent
-- Palm	0.08mm min.	0.08mm min.	Substantially equivalent
Physical Properties:	Meets ASTM D5250-06 (Reapproved 2011)
-- Elongation (Before/After aging)	≥300%	≥300%	Substantially equivalent
-- Tensile Strength (Before/After aging)	≥14MPa	≥14MPa	Substantially equivalent
Freedom from Pinholes	Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06; Inspection Level I, AQL 2.5	Meets ASTM D5151-06 (Reapproved 2011) (Holes Inspection Level I, AQI 2.5 mentioned in general for predicate, implied for subject)	Substantially equivalent
Residual Powder	Meets ASTM D 6124-06 (Reapproved 2011)	Results generated values below 2mg of residual powder	Substantially equivalent
Biocompatibility	SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10	The test article was a non-irritant or non-sensitizer. (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10)	Substantially equivalent

Note: The document explicitly states that the "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011)" and other relevant standards. The table re-iterates specific performance metrics where provided.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes used for the testing of the subject's device for each of the listed criteria (e.g., how many gloves were tested for length, width, tensile strength, pinholes, etc.).
The data provenance is not specified (e.g., country of origin of data). Given the manufacturer is from China, it's likely the testing was conducted there or by a lab associated with the manufacturer.
The data is retrospective, as it refers to tests conducted on manufactured products to demonstrate compliance with existing standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device and study. The "ground truth" for patient examination gloves is established by adherence to engineering and material performance standards (e.g., ASTM, ISO), not by expert consensus on interpretations of medical images or conditions. The standards themselves define the acceptable performance parameters.

4. Adjudication method for the test set:

This information is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies) to resolve disagreements among experts. Here, the assessment is based on objective measurements against predefined standards.

5. 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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices, often involving AI, where human readers interact with the device's output. The device in question is a patient examination glove, which does not involve human readers in the context of interpretation or diagnosis that would necessitate an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone performance study in the context of an "algorithm only" or "AI without human-in-the-loop" was not done. This device is not an algorithm or AI system. Its performance is assessed through physical and chemical testing against established standards.

7. The type of ground truth used:

The ground truth used is based on established industry standards and regulatory requirements. Specifically:
- ASTM Standard D 5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This defines physical characteristics like dimensions, tensile strength, elongation, and freedom from holes.
- ASTM D 5151-06 (Reaffirmation 2011): Standard Test Method for Detection of Holes in Medical Gloves. This specifies the water leak test for pinholes.
- ASTM D 6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
- 21 CFR 800.20: FDA regulation concerning medical gloves.
- ISO 10993-10: 2002/Amd. 1:2006(E): Biocompatibility testing for irritation and sensitization.

8. The sample size for the training set:

This information is not applicable. There is no "training set" in the context of a medical device like a patient examination glove. Training sets are used in machine learning or AI algorithm development. The gloves are manufactured and then tested to ensure they meet specifications.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Section C

510(k) 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: K131344 ." (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 :

Shijiazhuang Wally Plastic Co., Ltd. Submitter's name :

No. 78 Tongda Road, Jinzhou City. Hebei. 052260. China Submitter's address :

Zheng Jianming"

Phone number : (86) 31184322871

Fax number :

(86) 31184322871

Name of contact person:

18 Deceinber 2013 was Date. the summary prepared:

(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 Yellow Synthetic Vinyl Patient Examination Gloves
Proprietary/Trade name:	Powder Free Yellow Synthetic 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

Product Code :

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

Class I . Powder Free Yellow Synthelie Vinyl Patient Examination Gloves that meets all of the requirements of AST M'standard D 5250-06 (Reaffirmation 2011):

-Predicate device : POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD KIT0945

Section C (rev.02)

{1}------------------------------------------------

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

· Device Description : Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

-- How the device functions:

PVC films form a barrier to body fluids and bloodborne Pathogens

-- Scientific concepts that form the basis for the device

The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

るとかなる。 2017年の一日に ి.

మూలాలు
సంరక్షణ కా くなっています。

Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM:D5250 and ASTM D5151 requirements. 1 1 1 1 1 1 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

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

Device Intended Use: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.

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

The Powder Free Yellow Synthetic Vinyl Patient Examination Gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Features &Description	Predicate Device	Subject Device	Result ofComparison
510(k) Number	K110945-	K131344
Company	ZHAOYANG PLASTIC CO., LTD	Shijiazhuang Wally PlasticCo., Ltd.
Product name	POWDER-FREE YELLOWSYNTHETIC VINYL PATIENTEXAMINATION GLOVES	Powder Free YellowSynthetic Vinyl PatientExamination Gloves
Product Code	LYZ	LYZ	Same
Size	Small/ Medium/Large/X large	Small/ Medium/Large/X large	Small/Medium/Large/X large
Intend for use	POWDER-FREE YELLOWSYNTHETIC VINYL PATIENTEXAMINATION GLOVES is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner.	Powder Free YellowSynthetic Vinyl PatientExamination Gloves is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner.	Substantiallyequivalent
DeviceDescription andSpecifications	Meets ASTM D5250-06(Reapproved 2011)	Meets ASTM D5250 -06(Reapproved 2011)	Substantiallyequivalent
Dimensions --- Length	Meets ASTM D5250-06(Reapproved 2011)≥230mm min.	230mm min for all sizes	Substantiallyequivalent
Dimensions- Width	Meets ASTM D5250-06(Reapproved 2011)Small 80-90 mm	Small 80-85 mm	Substantiallyequivalent

	Dimensions-- Thickness	Medium 90-100mmLarge 100-110mmX large 110-120 mmMeets ASTM D5250-06(Reapproved 2011)	Medium 95-97 mmLarge 102-108mmX large 114-118 mm	Substantiallyequivalent
	PhysicalProperties	Finger 0.05mm min.Palm 0.08mm min.Meets ASTM D5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥14MPa	Finger 0.05mm min.Palm 0.08mm min.Before aging/after agingElongation ≥300%Tensile Strength≥14MPa	Substantiallyequivalent
	Freedom fromPinholes	Meets· 21 CFR 800.20· ASTM D5250-06(Reapproved 2011)· ASTM D 5151-06(Reapproved 2011)	Meets ASTMD5151-06(Reapproved 2011)HolesInspection Level IAQI 2.5	Substantiallyequivalent
	Residual Powder	Meets ASTMD 6124-06(Reapproved 2011)	D 6124-06(Reapproved 2011)Results generated valuesbelow 2mg of residualpowder	Substantiallyequivalent
	Compare allmaterials used tofabricate thedevices	PVC	PVC	Substantiallyequivalent
	Dusting orDonningPowder:	PU	PU	Substantiallyequivalent
	Dusting orDonningPowder: name	PU	Surface Coating Agent	Substantiallyequivalent
	Compareperformance datasupportingsubstantialequivalence	Meets· ASTM D5151-06(Reapproved 2011)· ASTM D5250-06(Reapproved 2011)· ASTM D6124-06(Reapproved 2011)	Meets· ASTM D5151-06(Reapproved 2011)· ASTM D5250-06(Reapproved 2011)· ASTM D6124-06(Reapproved 2011)	Substantiallyequivalent
	Single PatientUse	Single Patient Use	Single Patient Use	Substantiallyequivalent
	Biocompatibility	SKIN IRRITATION DERMAL andSENSITIZATION STUDIES MeetsISO 10993-10	The test article was anon-irritant ornon-sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10	Substantiallyequivalent.
	Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed:	-Powder-free-Patient Examination Glove-Yellow color-non sterile-Single Use Only-Manufactured For:-Lot	-Powder-free-Patient Examination Glove-Yellow color-non sterile-Single Use Only-Manufactured For:-Lot	Substantiallyequivalent

{2}------------------------------------------------

{3}------------------------------------------------

(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 Yellow Synthetic Vinyl Patient Examination Gloves meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Realfirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006(E).

[(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 the nonclinical and clinical 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 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 and the Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is as safe, as effective. and performs as well as the predicate device, POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHIAOYANG PLASTIC CO., LTD K110945

Section C (rev:02)

ವಾ

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three bars representing health, services, and people. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 30, 2014

Shijiazhuang Wally Plastics Company, Limited Mr. Chu Xiaoan Rm. 1606 Bldg.1 Jianxiang Yuan No.209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA

Re: K131344

Trade/Device Name: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 18, 2013 Received: December 20, 2013

Dear Mr. Xiaoan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{5}------------------------------------------------

Page 2 - Mr. Xiaoan

a problem and security and the production of the section of the section of the section of the section of the section of the section of the section of the section of the secti

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2.1 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

Sincerely vours.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Image /page/5/Picture/8 description: The image shows a signature or stamp with the text "Tejashri Purohit-Sheth, M.D." and "Clinical Deputy Director." Below that is the word "DAGRID" in a stylized font. The word "FOR" is in the bottom right corner of the image. The image appears to be a scan of a document with some handwritten elements.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K 131344

Device Name

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves

Indications for Use (Describe)

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a non-sterile intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

□ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

SC Publishing Services (101) 443-6740

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Image /page/6/Picture/11 description: The image shows a digital signature from the Center for Devices and Radiological Health (CDRH). The signature is from Sreekanth Gutala, and it includes the FDA logo. The date of the signature is January 24, 2014, at 15:08:17 -05'00'. The signature also includes a DN field with information about the signer's organization and identifier.

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

{7}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

· The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." .

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.