The Powder Free Grey Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

The proposed device. Powder Free Grey Vinvl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The proposed is Powder Free Grey Vinyl Patient Examination Gloves, and includes variations of different size.

AI/ML Overview

This document is a 510(k) premarket notification for disposable medical gloves. It compares a new device against a predicate device to demonstrate substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed)	Meets Acceptance Criteria?
General
Product Code	LYZ	LYZ	Yes
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	Yes
Class	I	I	Yes
Intended Use	Same as proposed	Same as predicate	Yes
Powdered or Powder free	Powdered free	Powdered free	Yes
Dimensions (Length)
Length, mm (all sizes)	≥240 min	≥230 min (for XS, S, M, L, XL, XXL)	See Note 1
Dimensions (Width, mm)
S (Predicate) / XS (Proposed)	85 ± 5	75 ± 5	See Note 2
M (Predicate/Proposed)	95 ± 5	95 ± 5	Yes
L (Predicate/Proposed)	105 ± 5	105 ± 5	Yes
XL (Predicate/Proposed)	115 ± 5	115 ± 5	Yes
Dimensions (Thickness, mm)
Finger	≥0.10 min	≥0.05 min	See Note 3
Palm	≥0.08 min	≥0.08 min	Yes
Cuff	≥0.06 min	≥0.06 min	Yes
Colorant	Blue	Grey	See Note 4
Physical Properties (Before Aging)
Tensile Strength	≥13 MPa, min	≥12 MPa, min	See Note 5
Ultimate Elongation	≥400 % min	≥300 % min	See Note 5
Physical Properties (After Aging)
Tensile Strength	≥13 MPa, min	≥12 MPa, min	See Note 5
Ultimate Elongation	≥400 % min	≥300 % min	See Note 5
Compliance with ASTM D5250 (Physical Properties)	Comply with ASTM D5250	Comply with ASTM D5250	Yes
Freedom from Holes (ASTM D5151)	Be free from holes	Be free from holes	Yes
Powder Content	Meet requirements of ASTM D5250	1.8 mg per glove	See Note 6
Material	Vinyl	Vinyl	Yes
Biocompatibility
Irritation (ISO 10993-10)	Not an irritant	Not an irritant	Yes
Sensitization (ISO 10993-10)	Not a sensitizer	Not a sensitizer	Yes
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	Yes

Notes on Acceptance Criteria Comparison:

Length: The proposed device lists a minimum length of ≥230mm, while the predicate states ≥240mm. The "Remark" for the proposed device states it "Complies with ASTM D5250," which would imply the 230mm is acceptable under the standard, despite being shorter than the predicate. This is a point of divergence that the FDA considered acceptable for substantial equivalence.
Width (XS vs S): The proposed device introduces an XS size (75mm width) not specified for the predicate. For equivalent sizes (S, M, L, XL), the widths match the predicate's tolerance.
Finger Thickness: The proposed device's minimum finger thickness (≥0.05 mm) is lower than the predicate (≥0.10 mm). Similar to length, the "Remark" states "Complies with ASTM D5250," indicating this lower thickness is still within standard limits.
Colorant: The color is different (Grey vs Blue). This is typically not a critical performance characteristic for gloves unless tied to a specific safety feature, and the document indicates "Complies with ASTM D5250."
Tensile Strength & Ultimate Elongation (Before & After Aging): The proposed device has lower minimum values for both tensile strength and ultimate elongation compared to the predicate. However, the "Remark" states "Complies with ASTM D5250," suggesting that these values, while lower than the predicate, still meet the requirements of the ASTM standard for medical application gloves. The FDA has accepted this as substantially equivalent.
Powder Content: The proposed device states "1.8 mg per glove." The predicate states "Meet the requirements of ASTM D5250." ASTM D6124-06 (Reaffirmation 2011) for residual powder is also listed as a standard the proposed device complies with, implying 1.8 mg per glove meets the standard's criteria.

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

The document describes "Bench tests" were conducted. It does not provide specific sample sizes for these tests (e.g., how many gloves were tested for length, width, thickness, holes, etc.).
It refers to standards like ASTM D5250, ASTM D5151, ASTM D6124, and ISO 2859-1. ISO 2859-1 ("Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection") describes sampling methods for quality control, but the specific sampling plan (e.g., AQL level, lot size, sample size) used for these tests is not detailed in this summary.
Data provenance: Not explicitly stated, but given the manufacturer (Zibo Flourish Trading Co., Ltd.) and the submission correspondent (Beijing Believe Tech. Service Co., Ltd.) are from China, it is highly probable the testing was conducted in China. The study appears to be a prospective test against specified standards for the new device.

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 and not provided for this type of medical device submission. The "ground truth" for glove performance is defined by adherence to recognized consensus standards (ASTM, ISO), not expert clinical adjudication or interpretation of complex medical data.

4. Adjudication method for the test set:

Not applicable and not provided. Performance is assessed by direct measurement and testing against predefined quantitative thresholds in standards, not by an adjudication panel interpreting subjective data.

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 submission for disposable patient examination gloves, not an AI-powered diagnostic device. No MRMC study or AI component is involved.

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

Not applicable. This is a physical medical device (gloves), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the performance of these gloves is based on established consensus standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 2859-1). For biocompatibility, it's based on the results of specific irritation and sensitization tests as outlined in ISO 10993-10.

8. The sample size for the training set:

Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI. The manufacturing process itself is subject to quality control, which involves ongoing testing and process validation, but this is distinct from an AI training set.

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

Not applicable, as there is no "training set" in this context.

Summary

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

July 14, 2016

Zibo Flourish Trading Co., Ltd. % Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town. Tongzhou Beijing, 101121 CHINA

Re: K161072

Trade/Device Name: Powder Free Grey Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 24, 2016 Received: June 27, 2016

Dear Mr. Wang:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director 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) K161072

Device Name

Powder Free Grey Vinyl Examination Gloves

Indications for Use (Describe)

Type of Use (Select one or both , as applicable)
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| Prescription Use (Part 21 CFR 801 Subpart D)

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

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Tab #2 510(k) Summary

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

The assigned 510(k) Number: K161072

1. Date of Preparation: 2016-6-24
1. Sponsor

ZIBO FLOURISH TRADING CO.,LTD NAQI ROAD,ZHANGDIAN DISTRICT,ZIBO CITY 255000,SHANDONG,P.R.CHINA

Contact Person: Ms. Kou Lingling Tel: +86- 0533-3819144 Fax: +86-0533-3818127 Email: hclijing85(@126.com

Submission Correspondent 3. Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd. Tel: +86-21-50313932 Fax: +86-21-68093116 Email: Ray.Wang(@believe-med.com
Proposed Device Identification 4.

Trade Name: Powder Free Grey Vinyl Examination Gloves Device Name: Vinyl Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves

Classification: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

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Intended Use Statement:

Predicate Device Identification న్.
510(k) Number: K150224 Product Name: Blue Vinyl Examination Gloves Powder free Manufacturer: Zibo Sanying Trade Co., Ltd.

6. Device Description

The proposed is Powder Free Grey Vinyl Patient Examination Gloves, and includes variations of different size.

Non-Clinical Test Conclusion 7.

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.

ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

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8. Substantially Equivalent Comparison Conclusion

ITEM	Proposed DevicePowder Free Grey Vinyl PatientExamination Gloves	Predicate Device (K150224)BLUE VINYL GLOVES POWDER FREE	Remark
Product Code	LYZ	LYZ	SE
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SE
Class	I	I	SE
Intended Use	The Powder Free Grey Vinyl PatientExamination Gloves is a disposable deviceintended for medical purposes that is wornon the examiner's hands or finger toprevent contamination between patient andexaminer.	The BLUE VINYL GLOVES POWDERFREE is a disposable device intended formedical purposes that is worn on theexaminer's hands or finger to preventcontaminationbetween patient andexaminer.	SE
Powdered orPowered free	Powdered free	Powdered free	SE

Table III-1 General Comparison
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	Designation	Size					Tolerance
Proposed DevicePowder Free Grey Vinyl PatientExamination Gloves		XS	S	M	L	XL	XXL
	Length, mm	≥230	≥230	≥230	≥230	≥230	≥230	min
	Width, mm	75	85	95	105	115	125	±5
	Thickness, mm:
	Finger	≥0.05						min
	Palm	≥0.08						min
	Cuff	≥0.06						min
Predicate Device (K150224)BLUE VINYL GLOVESPOWDER FREE		Size				Tolerance
	Designation	S	M	L	XL
	Length, mm	≥240	≥240	≥240	≥240		min
	Width, mm	85	95	105	115		±5
	Thickness, mm:
	Finger	≥0.10					min
	Palm	≥0.08					min
	Cuff	≥0.06					min
Remark	Complies with ASTM D5250

Table III-3 Device Dimensions Comparison

ITEM	Proposed Device	Predicate Device (K150224)	Remark
	Powder Free Grey Vinyl PatientExamination Gloves	BLUE VINYL GLOVESPOWDER FREE
Colorant	Grey	Blue	Complieswith ASTMD5250
PhysicalProperties	BeforeAgingTensileStrength	≥12 MPa, min	≥13 MPa, min	Complieswith ASTMD5250
	UltimateElongation	≥300 % min	≥400 % min
	AfterAgingTensileStrength	≥12 MPa, min	≥13 MPa, min
	UltimateElongation	≥300 % min	≥400 % min
	Comply with ASTM D5250	Comply with ASTM D5250	SE
Freedom from Holes	Be free from holes when tested inaccordance with ASTM D5151	Be free from holes when testedin accordance with ASTMD5151	SE
Powder Content	1.8 mg per glove	Meet the requirements of ASTM5250	SE

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ITEM	Proposed Device	Predicate Device (K150224)	Remark
	Powder Free Grey Vinyl PatientExamination Gloves	BLUE VINYL GLOVES POWDERFREE
Material	Vinyl	Vinyl	SE
Biocompatibility	Irritation	Under the conditions of the study, not an irritant	Comply with ISO 10993-10	SE
	Sensitization	Under conditions of the study, not asensitizer.
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	SE

Table III-4Safety Comparison

Conclusion

The Zibo Flourish Tading Co., LTD Powder Free Grey Vinyl Patient Examination Glove is substantially equivalent to the predicate device, Zibo Sanying Trade Co., LTD. Blue Vinyl Examination Gloves Powder Free. Based on the non-clinical tests performed, the subject device is as safe, as effective and performs as well as the legally marketed predicate device, cleared under K150224.

The proposed device, Powder Free Grey Vinyl Patient Examination Gloves, is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.

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.