Powder Free Viny! Patient Examination Gloves, Clear (Non-colored) 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 5250-06(Reaffirmation 2011). PVC films form a barrier to body fluids and bloodborne Pathogens. 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. 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.

AI/ML Overview

The provided text is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)." This type of regulatory submission demonstrates substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a study with the detailed elements requested.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The submission focuses on demonstrating that the new device has technological characteristics and performance that are equivalent to a legally marketed predicate device and complies with recognized standards.

Here's the information that can be extracted and a clear indication of what is not applicable:

Acceptance Criteria and Device Performance

Acceptance Criteria (Standard Requirement)	Reported Device Performance (Compliance)
Dimensions - Length (ASTM D5250-06 (Reapproved 2011) >230mm min.)	Subject Device: 230mm min for all sizes (Substantially equivalent)
Dimensions - Width (ASTM D5250-06 (Reapproved 2011))	Subject Device: Small 80-85 mm, Medium 95-97 mm, Large 102-108mm, X large 114-118 mm (These specific ranges are within the acceptable ranges of ASTM D5250-06, making it Substantially equivalent)
Dimensions - Thickness (ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min.)	Subject Device: Finger 0.05mm min., Palm 0.08mm min. (Substantially equivalent)
Physical Properties - Elongation (ASTM D5250-06 (Reapproved 2011) ≥300%)	Subject Device: Elongation ≥300% (Substantially equivalent)
Physical Properties - Tensile Strength (ASTM D5250-06 (Reapproved 2011) >14MPa)	Subject Device: Tensile Strength > 14MPa (Substantially equivalent)
Freedom from Pinholes (21 CFR 800.20, ASTM D5250-06, ASTM D5151-06; AQL 2.5 for Holes at Inspection Level I)	Subject Device: Meets ASTM D5151-06 (Reapproved 2011), Holes Inspection Level I AQL 2.5 (Substantially equivalent)
Residual Powder (ASTM D6124-06 (Reapproved 2011) < 2mg)	Subject Device: Results generated values below 2mg of residual powder (Substantially equivalent)
Biocompatibility (ISO 10993-10:2002/Amd.1:2006 for Skin Irritation and Sensitization Studies)	Subject Device: The test article was a non-irritant or non-sensitizer. Meets ISO 10993-10:2002/Amd.1:2006 (Substantially equivalent)
General Device Description and Specifications (Meets ASTM D5250-06 (Reapproved 2011))	Subject Device: Meets ASTM D5250-06 (Reapproved 2011) (Substantially equivalent)
Performance Data Supporting Substantial Equivalence	Subject Device: Meets ASTM D5151-06 (Reapproved 2011), ASTM D5250-06 (Reapproved 2011), ASTM D6124-06 (Reapproved 2011). (Substantially equivalent for all these criteria)

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a diagnostic test study. For the physical and biocompatibility testing (e.g., pinholes, tensile strength, residual powder, skin irritation), samples of the manufactured gloves would have been used. The exact number of units tested for each standard is not provided in this summary.
- Data Provenance: The manufacturing company is Friend Plastic Co., Ltd. in Shijiazhuang, China. The testing would presumably have been conducted in China or by a certified lab. The summary doesn't specify if the underlying testing data is prospective or retrospective, but it would have been generated specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This device is a Class I medical device (patient examination gloves) and does not involve the interpretation of medical images or diagnostic outputs that would require expert-established ground truth in the way a diagnostic AI device would. Compliance is determined by objective measurements against established ASTM and ISO standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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 not a diagnostic AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not a diagnostic AI device. The "performance" of the device is its physical and chemical properties.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective Measurement against Standards. The "ground truth" for this device's performance is objective measurements (e.g., length, width, thickness, tensile strength, elongation, residual powder, pinhole count) that meet predefined thresholds and specifications outlined in the referenced ASTM and ISO standards (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10) and regulatory requirements (21 CFR 800.20). Biocompatibility results (non-irritant, non-sensitizer) are also based on validated test methods.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The device is manufactured using a known process, and samples are tested for quality control and regulatory compliance.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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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:______K130891 " (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 :	Friend Plastic Co., Ltd.
Submitter's address :	#33, Ping An St., Shijiazhuang, 050000, China
Phone number :	(86) 311-67699886
Fax number :	(86) 311-67699906
Name of contact person:	Ms. Wang Li
Date the summary was prepared:	2014-02-07

{{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:	"Friend Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored)"
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

((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 5250-06 (Reaffirmation 2011).

Predicate device : Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908 .

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[(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 5250-06(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.

-- 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.

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

Device Intended Use: Powder Free Vinyl Patient Examination Gloves, 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, Clear (Non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Features & Description	Predicate Device	Subject Device	Result ofComparison
Company	Shijiazhuang FuguanPlastic Products Co., Ltd.	Friend Plastic Co., Ltd.	--
510(K) Number	K032908	K130891
Product name	Powder Free Vinyl PatientExamination Gloves, Clear(Non-colored)	Powder Free Vinyl PatientExamination Gloves, Clear(Non-colored)	Same
Product Code	LYZ	LYZ	Same
Size	Small/ Medium/Large/X large	Small/ Medium/Large/X large	Substantiallyequivalent
Intend for use	Powder free Vinyl PatientExamination Gloves,Clear(Non-colored)is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner.	Powder free Vinyl PatientExamination Gloves, Clear(Non-colored) is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner.	Substantiallyequivalent
Device Descriptionand Specifications	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)		Substantiallyequivalent
	Small 80-90 mmrMedium 90-100mmLarge 100-110mmX large 110-120 mm	Small 80-85 mmMedium 95-97 mmLarge 102-108mmX large 114-118 mm
Dimensions-- Thickness	Meets ASTM D5250-06 (Reapproved 2011)

Physical Properties	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> I4MPaMeets ASTM D5151-06(Reapproved 2011)	Substantiallyequivalent
FreedomfromPinholes	Meets- 21 CFR 800.20- ASTM D5250-06(Reapproved 2011)- ASTM D 5151-06(Reapproved 2011)	Meets ASTM D5151-06(Reapproved 2011)HolesInspection Level IAQL2.5	Substantiallyequivalent
Residual Powder	Meets ASTM D 6124-06(Reapproved 2011)	Meets ASTM D 6124-06(Reapproved 2011)Results generated values below2mg of residual powder	Substantiallyequivalent
Compare all materialsused to fabricate thedevices	PVC	PVC	Substantiallyequivalent
Dusting or DonningPowder:	PU	PU	Substantiallyequivalent
Dusting or DonningPowder: name	PU	Surface Coating Agent	Substantiallyequivalent
Compare performancedata supportingsubstantial equivalence	MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011)	MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011)	Substantiallyequivalent
Sterility status	Non sterile	Non sterile	Substantiallyequivalent
Single Patient Use	Single Patient Use	Single Patient Use	Substantiallyequivalent
Biocompatibility	SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO10993-10 :2002/Amd.1:2006	The test article was a non- irritantor non- sensitizer.SKIN IRRITATION DERMALand SENSITIZATION STUDIESMeets ISO10993-10 :2002/Amd.1:2006	Substantiallyequivalent
Labeling for thelegally marketeddevice to whichsubstantial equivalenceis claimed.	- Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot	- Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot	Substantiallyequivalent

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The manufacturing process has been described on the appendix 3.0.

[(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, Clear (Non-colored)meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 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

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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 and clinical tests that the device is as safe,as effective, and performed as well as 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 Vinyl Patient Examination Gloves, Clear (Non-colored) is as safe, as effective, and performs as well as the predicate device, Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908 .

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Public Health Service

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

February 18, 2014

Friend Plastic Company, Limited C/O Chu Xiaoan Beijing Easy-Link Company, Limited Room 1606 Building 1 Jian Xiang Yuan Number 209 Bei Si Huan Zhong Road Haidan District CHINA 100083

Re: K130891

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: December 25, 2013 Received: December 30, 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. Ilsting 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 - Mr. Xiaoan

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/MedicalDeyices/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/Medica/Devices/ResourcesforYou/Industry/default.htm.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K 130891

Device Name

Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)

、

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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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.