A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or lingers to prevent contamination between patient and examiner.

Device Description

White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.

AI/ML Overview

The provided document is a 510(k) summary for the "White Vinyl Exam Gloves Powder Free." This is a medical device application for approval based on substantial equivalence to an already marketed predicate device, not a clinical study report for an artificial intelligence or diagnostic device. Therefore, many of the requested elements are not applicable to this type of submission.

However, I can extract the acceptance criteria and performance data as presented for the non-clinical tests conducted to demonstrate substantial equivalence of the proposed device to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (medical gloves), the "acceptance criteria" are typically defined by recognized standards (like ASTM D5250-06) and the performance of the predicate device. The "device performance" refers to the results obtained from testing the proposed device against these standards and in comparison to the predicate.

Characteristic	Acceptance Criteria (from ASTM D5250-06 and/or Predicate)	Proposed Device Performance (Shandong Dawei Medical Products Co., Ltd. White Vinyl Exam Gloves Powder Free)
Before Aging: Tensile Strength (Mpa)	Average Tensile Strength (Mpa): 16.80 (Predicate)	Average Tensile Strength (Mpa): 16.84
Before Aging: Ultimate Elongations	Average Ultimate Elongations: 510% (Predicate)	Average Ultimate Elongations: 520%
After Aging: Tensile Strength (Mpa)	Average Tensile Strength (Mpa): 15 (Predicate)	Average Tensile Strength (Mpa): 14.96
After Aging: Ultimate Elongations	Average Ultimate Elongations: 480% (Predicate)	Average Ultimate Elongations: 481%
Overall Length on Medium Size	Average over 232mm (Predicate)	Average over 232.23mm
Width of Palm on Medium Size	Average 96mm (Predicate)	Average 95mm
Palm Thickness	Average 0.096 mm (Predicate)	Average 0.095 mm
Figure Thickness	Average 0.091 mm (Predicate)	Average 0.090 mm
Residual Powder	< 2 mg per glove (ASTM D6124-06)	< 2 mg per glove, no defect glove found
Pinhole Results	Pinhole found less than two pieces gloves out of 125 pieces gloves (AQL 2.5) (ASTM D5151-06)	Pinhole found less than two pieces gloves out of 125 pieces gloves (AQL 2.5 is met)
Primary Skin Irritation	Not an irritant (Predicate)	Not an irritant
Dermal Sensitization	Not a sensitizer (Predicate)	Not a sensitizer

The study that proves the device meets the acceptance criteria:

The study is described as "Non-Clinical tests performed for Determination of Substantial Equivalence." These tests were conducted based on ASTM standards (D5250-06, D6124-06, D5151-06) and FDA's 1000 ml. Water Fill Test. Biocompatibility testing (Primary Skin Irritation and Skin Sensitization) was also performed. The conclusion states that the proposed device conforms fully to ASTM-D-5250-06 standard, applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements, and labeling claims.

Regarding the other requested information, most are not applicable to this type of device submission:

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

Test Set Sample Size: For physical tests (Tensile Strength, Elongation, Dimensions, Thickness), specific sample sizes are not explicitly stated beyond "samplings of AQL 2.5" for the Water Fill Test and "125 pieces gloves" for pinhole testing. The number of gloves tested for other physical properties is not detailed.
Data Provenance: The tests were conducted by the manufacturer, Shandong Dawei Medical Products Co., Ltd., presumably in China, to demonstrate compliance with US FDA regulations. The data is retrospective, as it's generated for a submission of a completed device.

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

Not applicable. This is not an AI/diagnostic device where expert ground truth is typically established. The "ground truth" here is defined by objective physical and chemical testing against established engineering standards and regulatory requirements.

4. Adjudication method for the test set:

Not applicable. Not an AI/diagnostic device. Performance is determined by objective measurements against quantitative 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:

Not applicable. This is a medical glove, not an AI or diagnostic device designed to be used by human readers for interpretation.

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

Not applicable. This is a physical medical device (glove), not an algorithm.

7. The type of ground truth used:

For Physical/Performance Properties: The "ground truth" is defined by the objective measurements obtained from testing the gloves, compared against the specified limits in ASTM standards (D5250-06, D6124-06, D5151-06) and the performance characteristics of the legally marketed predicate device (K992821).
For Biocompatibility: The "ground truth" for primary skin irritation and dermal sensitization is determined by the results of specific biological tests, indicating whether the device elicited an irritant or sensitizing response.

8. The sample size for the training set:

Not applicable. This is not an AI device, so there is no "training set." The product is manufactured according to specifications derived from standards.

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

Not applicable. There is no training set as it is not an AI device.

Summary

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Ki403zz

510 (K) SUMMARY

JUN 1 2 2014

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

1. Submitter's Identification:
  Shandong Dawei Medical Products Co., Ltd. No.50. Yongzhou Road Nanshan Industrial Park, Qingzhou, Shandong, 262500 China

Date summary prepared: June 4, 2014

1. Name of the Device:
  White Vinyl Exam Gloves Powder Free
1. Common name/classification name of the Device:
  White Vinyl Exam Gloves Powder Free
1. Trade Name
  White Vinyl Exam Gloves Powder Free

5. Contact Person:

Sophie Hao, Tel: 909-548-4828 Email: sophie.hxf1989@gmail.com

6. Predicate Device Information:

Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)

7. Device Description:

Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free

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Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.

8. Intended Use:

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or linger to prevent contamination between patient and examiner.

(). Comparison to Predicate Devices:

Shandong Dawei Medical Products Co., Ltd. White Vinvi Exam Gloves Powder Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. (K992821)

1 (). Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:

The standards used for Shandong Dawei Medical Products Co., I.td. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQI. 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5. Inspection Level I, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

1. Discussion of Clinical Tests Performed:
  Not Applicable - There is no hypoallergenic claim.

l 2. Conclusions:

The conclusion draws from the nonclinical and clinical test that demonstrate that the as safe, as effective, and performs as well as, or better than the legally market predicate device Shijiazhuang Hongxiang Plastic Products Co., Ltd. Powder-free Vinyl Patient Examination Gloves (K992821). Our White Vinvl Exam Gloves Powder Free conform fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims.

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Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material,
Physical, Biocompatibility, and Performance Testing

100 - 100 -

	Proposed Device	Predicate Device (K992821)
	Shandong Dawei Medical Products Co.,	Shiiiazhuang Hongxiang
Description	Ltd. White Vinyl Exam Gloves Powder	Powder-free Vinyl Patient
	Free	Examination Gloves
	A garment covering the hand and wrist	A garment covering the hand
Labeling: Instruction	area. Clovers have separate openings for	and wrist area. Clovers have
for use	each finger and the thumb.	separate openings for each
		finger and the thumb.
		Substantially equivalent
	Labels include: Product name: color;	Labels include: Product name;
Labeling: Labels on	"single use Only" size, piece count, lot	"single use Only" size, piece
the carton	distributornumber.name.and	count, distributor name, and
	manufacturer address.	manufacturer address.
		Substantially equivalem
	disposable device intendedর্বfor	A disposable device intended
	medical purposes that is worn upon the	for medical purposes that is
	examiner's hands or lingers to prevent	upon the examiner'sworn
Indication For Use	contamination between patientand	hands or fingers to prevent
	examiner.	contamination between patient
		and examiner.
		Substantially equivalent
	Poly Vinyl Chloride	Poly Vinvl Chloride
Device Materials	Polyurethane	Polyurethane
	Diisononyl Phthalate (DINP)	Diisononyl Phthalate (DINP)
	Average Tensile Strength (Mpa): 16.84	TensileStrengthAverage
Before Aging: Tensile	Average Ultimate Elongations: 520%	(Mpa): 16.80
Strength(Mpa) and		Average Ultimate Elongations:
Ultimate Elongations		510%
		Substantially equivalent
	Average Tensile Strength (Mpa): 14.96	AverageTensileStrength
After Aging: Tensile	Average Ultimate Elongations: 481%	(Mpa): 15
Strength(Mpa) and		Average Ultimate Elongations:
Ultimate Elongations		480%
		Substantially equivalent
Overall Length on	Average over 232.23mm	Average over 232mm
Medium Size		Substantially equivalent
Width of Palm on	Average 95mm	Average 96 mm
Medium Size		Substantially equivalent
	Average 0.095 mm	Average 0.096 mm
Palm Thickness		Substantially equivalent
Figure Thickness	Average 0.090 mm	Average 0.091 mm

Residual Powder	According to ASTM D6124-06Standard Test Method for ResidualPowder on Medical gloves for thedetermination of residual powdercontent. Testing result indicates theweight of all types of residual or powderon finished powder-free gloves as < 2mg per glove and there is no defectglove found according to ASTMD6124-06.	According to ASTM D6124-06the weight of all types ofresidual or powder on finishedpowder-free gloves as < 2 mgper glove and there is no defectglove found according toASTM D6124-06.
Pinhole Results	According to ASTM D5151-06. Testingresult indicates pinhole were found lessthan two pieces gloves out of 125 piecesgloves. AQL 2.5 is met.	According to ASTM D5151-06. testing result indicatespinhole were found less thantwo pieces gloves out of 125pieces gloves. AQL 2.5 is met.Substantially equivalent
BiocompatibilityResult: Primary SkinIrritation	Under the condition of the study, thedevice is not an irritant	not an irritant.Substantially equivalent
Dermal Sensitization	Under the condition of the study, thedevice is not a sensitizer	not a sensitizerSubstantially equivalent
Summary ofcomparison	Shandong Dawei Medical Products Co., Ltd. White Vinyl Exam GlovesPowder Free (subject device) and Shijiazhuang Hongxiang Powder-freeVinyl Patient Examination Gloves (predicate device) are substantiallyequivalent in all technological characteristics, including tensile strength,ultimate elongations size, thickness, residual powder and pinhole.

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100 million in the state

and the comments of the comments of the comments of

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

June 12, 2014

Shandong Dawei Medical Products Company, Limited C/O Ms. Sophie Hao Official Correspondent Basic Medical Industries Incorporated 12390 East End Avenue Chino, CA 91710

Re: K140322

Trade/Device Name: White Vinyl Exam Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 5, 2014 Received: May 8, 2014

Dear Ms. Hao:

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.

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Page 2 - Ms. Hao

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 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/ResourcesforYou/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 (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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

: :

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

Sincerely yours.

ਕਿ 1 (ਅਤੇ 1 (ਸੂਬਾ) ਦੇ ਵਿੱਚ ਇੱਕ Telasbri Purobit-Sheth, M.D. Tejashri Purofrit-Sheth; M.O. Clinical Deputy Director STATUS CONSTITUTION DAGRIDIOD DAGRID/ODE/CDRH FOR

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) ド140322

Device Name

White Vinyl Exam Gloves Powder Free

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or lingers 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)

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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.