The Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device: "Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical benefit. Therefore, the information provided relates to performance against recognized standards and comparison to predicates, not a traditional clinical study with human readers or training sets as might be seen for AI algorithms.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents performance information in Tables 2, 3, and 4 (starting on page 6), comparing the proposed device to predicate devices and referencing ASTM and ISO standards for acceptance criteria.

Acceptance Criterion (Standard Ref.)	Proposed Device Performance (K182043)	Predicate Device (K163168) Performance	Predicate Device (K180849) Performance
Dimensions (Table 2)
Length, mm (min)	240	230 (XS, S), 235 (M), 245 (L, XL)	230 (S), 235 (M), 245 (L, XL)
Width, mm ($\pm$5)	80 (XS), 85 (S), 95 (M), 105 (L), 115 (XL)	80 (XS), 85 (S), 95 (M), 105 (L), 115 (XL)	85 (S), 95 (M), 105 (L), 115 (XL)
Finger Thickness, mm (min)	0.07	0.05	0.05
Palm Thickness, mm (min)	0.08	0.08	0.08
Physical Properties (Table 3)
Before Aging (ASTM D5250)
Tensile Strength, MPa (min)	15	15	15
Ultimate Elongation, % (min)	350	380	380
After Aging (ASTM D5250)
Tensile Strength, MPa (min)	15	15	15
Ultimate Elongation, % (min)	350	380	380
Freedom from Holes (ASTM D5151)	Be free from holes, AQL=1.5	Be free from holes, AQL=1.5	Be free from holes, AQL=1.5
Powder Content (ASTM D6124)	0.33 mg	Meet ASTM 5250 requirements	Meet ASTM 5250 requirements
Biocompatibility (Table 4)
Irritation (ISO 10993-10)	Not an irritant	Not an irritant / Comply with ISO 10993-10	Comply with ISO 10993-10
Sensitization (ISO 10993-10)	Not a sensitizer	Not a sensitizer / Comply with ISO 10993-10	Comply with ISO 10993-10
Cytotoxicity (ISO 10993-5)	Did not show potential toxicity to L-929 cells	/	Comply with ISO 10993-5
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	Meet FDA's Requirements

Differences noted and addressed:

Length (Analysis 1): The proposed device has a different length than the predicate, but test results according to ASTM 5250 showed it meets standard requirements.
Colorant (Analysis 2): The proposed device is clear/non-colored, while one predicate is white, blue, or yellow. The submission argues that color difference does not affect safety and effectiveness, supported by biocompatibility testing (ISO 10993-5 and ISO 10993-10).
Ultimate Elongation (Analysis 3): The proposed device has a different ultimate elongation value than the predicate, but test results according to ASTM 5250 showed it meets standard requirements.

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

Sample Size: The document does not explicitly state the sample size for each specific test (e.g., number of gloves tested for tensile strength, freedom from holes, etc.). However, it refers to standards such as 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"), which would dictate the appropriate sample sizes for quality control testing based on lot size and AQL levels. For example, for "Freedom from Holes," an AQL of 1.5 is specified, which implies a specific sampling plan from ISO 2859-1.
Data Provenance: The tests were conducted by the "HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD." in China, as indicated by the sponsor's identification. These are non-clinical (bench) tests supporting the device's conformance to established industry standards. The data is thus generated internally by the manufacturer for the purpose of this submission.
Retrospective or Prospective: These are laboratory/bench tests that are inherently "prospective" in the sense that they are performed on manufactured product samples to demonstrate compliance with specifications.

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 submission. The "ground truth" for medical gloves is established by predefined engineering specifications and performance criteria codified in international standards (e.g., ASTM D5250, ISO 10993 series). The tests are evaluated against these objective numerical or qualitative criteria, not by expert consensus in a clinical context.

4. Adjudication method for the test set:

Not applicable. This device is evaluated against objective technical standards (ASTM, ISO). There is no "adjudication" of expert opinions for a test set in this context.

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 submission is for single-use medical examination gloves, which are not AI-enabled devices and do not involve human readers interpreting diagnostic images.

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

Not applicable. This is not an AI algorithm. The device's performance is standalone in the sense that it meets physical and biocompatibility specifications on its own, without requiring human interpretation for its intended function.

7. The type of ground truth used:

The "ground truth" for this device's performance is defined by the objective, measurable parameters and criteria stipulated in the referenced international standards:

ASTM D6124 (Residual Powder)
ASTM D5151 (Detection of Holes)
ASTM D5250 (Poly(vinyl chloride) Gloves for Medical Application)
ISO 10993-10 (Irritation and Skin Sensitization)
ISO 10993-5 (In Vitro Cytotoxicity)
ISO 2859-1 (Sampling Procedures)

These standards specify the methods for testing and the acceptable limits or qualities (e.g., minimum tensile strength, maximum powder content, AQL for freedom from holes, non-irritant/non-sensitizer for biocompatibility).

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

Summary

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September 21, 2018

Hebei Titans Hongsen Medical Technology Co., LTD. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5 YiHe North Rd., FangShan District Beijing, 102401 Cn

Re: K182043

Trade/Device Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 23, 2018 Received: July 30, 2018

Dear Ray 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Tina Kiang, Ph.D. 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)

K182043

Device Name

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

Indications for Use (Describe)

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This 510(k) Summary is being submitted in accordance with Title 21, CFR Section 807.92.

The assigned 510(k) Number: K182043

1. Date of Preparation:2018/08/18
1. Sponsor Identification

HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD. EASTERN INDUSTRIAL ZONE, NANGONG CITY, HEBEI PROVINCE, CHINA

Contact Person: Mr. ShaoZhang Nan Tel: +86-0319-7295820 Fax: +86-0319-7295801 Email: nanshaozhang@163.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Tel: +86-18910677558, Fax: +86-10-56335780 Email: Ray.Wang(@believe-med.com

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4. Identification of Proposed Device

Trade Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): XS S M L XL

Regulatory Information Classification Name: Vinyl Patient Examination Gloves (Powder Free) Classification:1 Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for use Statement:

1. Device Description
  The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

6. Identification of Predicate Device(s)

Predicate Device K163168 Vinyl Patient Examination Gloves (White, Blue, Yellow) Hebei Hongtai Plastic Products Company Limited

K180849 Vinyl Examination Glove (Clear, Non-Colored) HUIFU TRADING CO., LTD.

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ITEM	Proposed Device (K182043)	Predicate Device (K163168)	Predicate Device (K180849)	Remark
Product Code	LYZ	LYZ	LYZ	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	21 CFR 880.6250	SAME
Class	I	I	I	SAME
Intended Use	The Single-use medical poly(vinyl chloride) examinationglove (Clear, Non-Colored) isa disposable device intendedfor medical purposes that isworn on the examiner's handsto prevent contaminationbetween patient and examiner.	The Vinyl Examination Glove(White, Blue, or Yellow) is adisposable device intended formedical purposes that is worn onthe examiner's hands to preventcontamination between patientand examiner.	The Vinyl PatientExamination Glove (Clear,Non-Colored) is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hands to preventcontamination between patientand examiner.	SAME
Powdered orPowered free	Powdered free	Powdered free	Powdered free	SAME
Design Feature	ambidextrous	ambidextrous	ambidextrous	SAME
Surface Feature	Smooth	Smooth	Smooth	SAME
LabelingInformation	Single-use indication, powderfree, device color, devicename, glove size and quantity,Vinyl Examination Gloves,Non-Sterile	Single-use indication, powderfree, device color, device name,glove size and quantity, VinylExamination Gloves, Non-Sterile	Single-use indication, powderfree, device color, devicename, glove size and quantity,Vinyl Examination Gloves,Non-Sterile	SAME

7. Technological Comparison

Table 1 General Comparison

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	Designation	Size					Tolerance
		XS	S	M	L	XL
Proposed Device (K182043)	Length, mm	240	240	240	240	240	min
	Width, mm	80	85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.07					min
	Palm	0.08					min
Predicate Device (K163168)	Designation	XS	S	M	L	XL	Tolerance
	Length, mm	230	230	235	245	245	min
	Width, mm	80	85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Predicate Device (K180849)	Designation		S	M	L	XL	Tolerance
	Length, mm		230	235	245	245	min
	Width, mm		85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Remark	Analysis 1

Table 2 Device Dimensions Comparison

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ITEM	Proposed Device(K182043)	Predicate Device(K163168)	Predicate Device(K180849)	Remark
Colorant	Clear, Non-Colored	White, Blue,Yellow	Clear,Non-Colored	Analysis 2
PhysicalProperties	BeforeAging	TensileStrength15 MPa, min	15 MPa, min	15 MPa, min	Analysis 3
	UltimateElongation	350 % min	380 % min	380 % min
	AfterAging	TensileStrength15 MPa, min	15 MPa, min	15 MPa, min
	UltimateElongation	350 % min	380 % min	380 % min
	Comply with ASTM D5250		Comply withASTM D5250	Comply withASTM D5250	SAME
Freedom from Holes	Be free from holeswhen tested inaccordance withASTM D5151AQL=1.5		Be free from holeswhen tested inaccordance withASTM D5151AQL=1.5	Be free from holeswhen tested inaccordance withASTM D5151AQL=1.5	SAME
Powder Content	0.33 mg		Meet therequirements ofASTM 5250	Meet therequirements ofASTM 5250	SAME

Table 3 Performance Comparison

Table 4 Safety Comparison

ITEM	Proposed Device (K182043)	Predicate Device(K163168)	Predicate Device(K180849)	Remark
Material	Vinyl	Vinyl	Vinyl	SAME
Biocompatibility	Irritation	Under the conditions of thestudy, not an irritant	Comply with ISO10993-10	Comply with ISO10993-10	SAME
	Sensitization	Under conditions of the study,not a sensitizer.	Comply with ISO10993-10	Comply with ISO10993-10	SAME
	Cytotoxicity	Under conditions of the study,did not show potential toxicityto L-929 cells.	/	Comply with ISO10993-5	SAME
Label and Labeling		Meet FDA's Requirements	Meet FDA'sRequirements	Meet FDA'sRequirements	SAME

Analysis 1:

The proposed device has different Length to the predicate device, but all proposed devices are conducted the test according ASTM 5250, the test results shown that the Length of proposed device meet the

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requirements of standard.

Analysis 2:

The proposed device has different color to the predicate device, but all proposed devices are conducted the test according ISO 10993-5 and ISO 10993-10 for Irritation and Cytotoxicity, and other non-clinical bench test.

The test results shown that the performance of proposed device meet the requirements of standard and no potential biocompatibility issues.

So, the different color would not effects the safety and effectiveness of proposed device.

Analysis 3:

The proposed device has different Ultimate Elongation to the predicate device, but all proposed devices are conducted the test according ASTM 5250, the test results shown that the Ultimate Elongation of proposed device meet the requirements of standard.

8. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro A Cytotoxicity
ASTM D6124-06 (Reaffirmation 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical > Gloves.
ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
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.
Clinical Test Conclusion 9.

Clinical testing is not needed for this device.

1. Conclusion
  The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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.