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

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

Device: Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ASTM D5250-06 and FDA requirements)	Reported Device Performance (Zibo Intco Medical Products)
Physical and Dimensions Testing:	Inspection Level S-2, AQL 2.5 was met.
- Tensile Strength (Mpa) - Before Aging	Average 19.2 Mpa
- Ultimate Elongations (%) - Before Aging	Average 501%
- Tensile Strength (Mpa) - After Aging	Average 16.8 Mpa
- Ultimate Elongations (%) - After Aging	Average 472%
- Overall Length (Medium Size)	Average over 249mm (Meets predicate's "Substantially equivalent")
- Width of Palm (Medium Size)	Average 95mm (Meets predicate's "Substantially equivalent")
- Palm Thickness	Average 0.085 mm (Meets predicate's "Substantially equivalent")
- Figure Thickness	Average 0.088 mm (Meets predicate's "Substantially equivalent")
Key Performance Attributes:
- Residual Powder (per glove)	< 2 mg (according to ASTM D6124-06)
- Pinhole Results (AQL)	Less than 2 defective gloves out of 125, AQL 2.5 met (according to ASTM D5151-06)
Biocompatibility Testing:
- Primary Skin Irritation	Not an irritant
- Dermal Sensitization (Allergic Contact Dermatitis)	Not a sensitizer

2. Sample Size Used for the Test Set and Data Provenance

Physical and Dimensions Testing, Pinhole Results: Inspection Level S-2, AQL 2.5 for physical/dimensions and Inspection Level I, AQL 2.5 for the FDA 1000 ml. Water Fill Test (pinhole). The specific number of gloves tested is implicitly defined by these AQL (Acceptable Quality Limit) levels and inspection levels, but the exact sample number isn't stated directly. For pinhole, it specifies "125 pieces gloves" were tested.
Residual Powder: Not explicitly stated, but performed according to ASTM D6124-06.
Biocompatibility (Primary Skin Irritation, Skin Sensitization): Not explicitly stated, but testing was conducted.
Data Provenance: The testing was performed by Zibo Intco Medical Products, Co. Ltd. in China, as per the submitter's identification. The data is retrospective, as it's part of a 510(k) submission showing pre-market testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this device. The "ground truth" for glove performance characteristics like tensile strength, pinholes, or powder content is established by standardized testing methods (e.g., ASTM standards) and objective measurements, not by expert consensus or clinical interpretation. Biocompatibility testing results (irritation/sensitization) are also objective findings from laboratory tests, not expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are objective laboratory measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and the AI's impact on their performance is being assessed. This device is a medical glove, which does not involve human interpretation in the same way.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product (medical glove), not an algorithm or AI software. The performance testing focuses on the physical properties and biological compatibility of the glove itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Standardized Measurement: Adherence to established performance standards defined by ASTM (American Society for Testing and Materials) such as D5250-06, D6124-06, and D5151-06.
Laboratory Testing: Objective results from physical, chemical, and biological laboratory tests (e.g., tensile strength, elongation, residual powder measurement, water fill test for pinholes, primary skin irritation test, skin sensitization test).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical product, not a machine learning model or algorithm, so there is no "training set" in the computational sense. The testing performed is to validate the manufacturing process and product characteristics.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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510 (K) SUMMARY

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:
  Zibo Intco Medical Products, Co. Ltd. No. 18, Qingtian Road. Qilu Chemical Industry Park Zibo. Shandong Province China

Date summary prepared: March 23, 2014

1. Name of the Device:
  Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves. Yellow Color
Common name/classification name of the Device: 3.
Powder-Free Vinyl Patient Examination Gloves, Yellow Color

4. Contact Person:

Jennifer Guo, Tel: 909-548-4828

Predicate Device Information: ಳು

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

Device Description: 6.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.

1. Intended Use:
  A patient examination ylove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

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8. Comparison to Predicate Devices:

Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. (K992821) and Shanghai Jiawang Industrial Co., Ltd. (K031854)

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

The standards used for Zibo Intco Medical Products. Co. Ltd. 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. AQL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 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).

Discussion of Clinical Tests Performed: 10.

Not Applicable - There is no hypoallergenic claim.

11. Conclusions:

Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves. Yellow Color 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 as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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	Proposed Device	Predicate Device(K992821)
Description	Zibo Intco Medical Products, Co. LtdPowder-Free Vinyl PatientExamination Gloves, Yellow Color	Shijiazhuang HongxiangPowder-free Vinyl PatientExamination Gloves
Product Code	LYZ	LYZ
Indications for Use	A disposable device intended formedical purposes that is worn upon theexaminer's hands or fingers to preventcontamination between patient andexaminer.	Substantially equivalent
Type of Use	Over-The-Counter Use	Substantially equivalent
Labeling: Instructionfor use	A garment covering the hand and wristarea. Clovers have separate openingsfor each finger and the thumb.	Substantially equivalent
Labeling: Labels onthe carton	Labels include: Product name; color;"single use Only" size, piece count, lotnumber, distributor name. andmanufacturer address.	Substantially equivalent
Device Materials	Poly Vinyl ChloridePolyurethaneDiisononyl Phthalate (DINP)	Substantially equivalent
Before Aging:Tensile,Strength(Mpa) andUltimate Elongations	Average Tensile Strength (Mpa): 19.2Average Ultimate Elongations: 501%	Substantially equivalent
After Aging: TensileStrength(Mpa) andUltimate Elongations	Average Tensile Strength (Mpa): 16.8Average Ultimate Elongations: 472%	Substantially equivalent
Overall Length onMedium Size	Average over 249mm	Substantially equivalent
Width of Palm onMedium Size	Average 95mm	Substantially equivalent
Palm Thickness	Average 0.085 mm	Substantially equivalent
Figure Thickness	Average 0.088 mm	Substantially equivalent
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 orpowder on finished powder-freegloves as < 2 mg per glove and there isno defect glove found according toASTM D6124-06.	Substantially equivalent
Pinhole Results	According to ASTM D5151-06,Testing result indicates pinhole werefound less than two pieces gloves outof 125 pieces gloves. AQL 2.5 is met.	Substantially equivalent
BiocompatibilityResult: Primary SkinIrritation	Not an irritant	Substantially equivalent
Dermal Sensitization	Not a sensitizer	Substantially equivalent
Summary ofcomparison	Zibo Intco Medical Products, Co. Ltd Powder-Free Vinyl PatientExamination Gloves, Yellow Color (subject device) and ShijiazhuangHongxiang Powder-free Vinyl Patient Examination Gloves (predicatedevice) are substantially equivalent in all technologicalcharacteristics, including tensile strength, ultimate elongations,thickness, residual powder and pinhole.

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

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Public Health Service

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

May 1, 2014

Zibo Intco Medical Products Company, Limited C/O Frank Liu Basic Medical Industries, INC 12390 East End Avenue Chino, California 91710

Re: K132637

Trade/Device Name: Powder - free Vinyl Patient Examination Gloves, Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 24, 2014 Received: March 27, 2014

Dear Mr. Liu:

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 - Mr. Liu

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 (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 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 (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tejashri Purohit Sheth, M.D.
Director
Tejashri Purohit-Shath MD Chilean Deputy Dir
DAGRID/ODE/CDRH FOR

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 Orug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132637

Device Name

Powder-free Vinyl Patient Examination Gloves. Yellow Color

Indications for Use (Describe)

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

図 Over-The-Counter Use (21 CFR 801 Subpan C)

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

FOR FDA USE ONLY

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

Elizabeth F. Clave 2014.04.30 15:39:09

FORM FDA 3881 (1/14)

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.