LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) by ELIMEDICAL DEVICES (FUJIAN) INC.

A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free) is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex. per standard ASTM D3577-0961, the rubber surgical gloves classification is: "Type 1 - gloves compounded primarily from natural rubber latex". The proposed device include Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same colour, creamy white. The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10% and place in a sterility maintenance package to ensure a shelf life of 3 years.

AI/ML Overview

The provided text is a 510(k) summary for Latex Surgeon's Gloves. This document focuses on demonstrating Substantial Equivalence (SE) to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance, especially not in the context of an AI-powered diagnostic or medical imaging device.

Therefore, many of the requested sections related to AI performance, clinical studies, ground truth establishment, expert adjudication, and sample sizes for AI training/testing are not applicable to this type of submission.

However, I can extract the acceptance criteria (which are largely compliance with established ASTM and ISO standards) and the "device performance" as reported through these benchmark tests.

Acceptance Criteria and Device Performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance
Physical Properties (Comply with ASTM D3577)	Comply with ASTM D3577
Freedom from Holes (Comply with ASTM D3577 and ASTM D5151)	Comply with ASTM D3577 and ASTM D5151
Powder Content (Comply with ASTM D3577 and ASTM D6124)	Comply with ASTM D3577 and ASTM D6124
Protein Content (Comply with ASTM D3577, ASTM D5712 and ASTM D6499)	Comply with ASTM D3577, ASTM D5712 and ASTM D6499
Biocompatibility (Comply with ISO 10993-10)	Comply with ISO 10993-10
Sterilization (Radiation, SAL: 10-6)	Radiation, SAL: 10-6
Dimensions (Comply with ASTM D3577 for specified sizes)	Comply with ASTM D3577 for sizes 6, 6½, 7, 7½, 8, 8½, 9
Packaging Seal Integrity (Comply with ASTM F1929 and ASTM F88/F88M)	(Implied by "Bench tests were conducted to verify that the proposed device met all design specifications," though not explicitly listed in the comparison table)
Sterilization Dose (Comply with ISO11137-2)	(Implied by "Bench tests were conducted," though not explicitly listed in the comparison table)
Label and Labeling (Meet FDA's Requirements)	Meet FDA's Requirements

Study Details (Non-Applicable for AI/Diagnostic Device)

Since this is a submission for a Latex Surgeon's Glove and relies on bench testing against established standards for substantial equivalence, the following sections are not relevant to this type of medical device submission.

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical gloves tested according to ASTM and ISO standards. The document does not specify the number of gloves tested for each standard, nor their country of origin (beyond the manufacturer being in China). The tests are inherently retrospective in nature, as they evaluate manufactured products.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" for glove performance is defined by the objective measurements and pass/fail criteria within the ASTM and ISO standards, not by expert consensus in the diagnostic sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is determined by adherence to quantitative and qualitative criteria defined in the standards.
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 an AI/diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance is established by the definitions and pass/fail criteria within the referenced ASTM and ISO consensus standards. For example, "Freedom from Holes" is determined by a specific test method (ASTM D5151) that provides an objective result.
The sample size for the training set: Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Acceptance:

The submission confirms that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The study essentially involved performing the tests specified by recognized consensus standards:

ASTM D3577-09e1: Standard Specification for Rubber Surgical Gloves (covers dimensions, physical properties, freedom from holes, powder content, protein content).
ASTM D5151-06 (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.
ASTM D5712-10: Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
ASTM D6499-07: Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
ASTM F1929-98 (2004): Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ASTM F88/F88M-09: Standard Test Method for Seal Strength of Flexible Barrier Materials.
ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (biocompatibility).
ISO11137-2: 2006: Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose.

The conclusion drawn from these bench tests was that the "test results demonstrated that the proposed device complies with the following standards" and therefore is Substantially Equivalent to the predicate device, K063757. The specific numerical results of these tests and the exact sample sizes used for each test are not detailed in this 510(k) summary, but compliance implies that the tested samples met the criteria set forth in these standards.

Summary

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Section III 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.

K130301 The assigned 510(k) Number:

1. Date of Submission: January 11, 2013
1. Sponsor

AUG 2 2 2013

Elimedical Devices(Fujian) Inc. E06, Wuping Industrial Park, Wuping, Fujian 364300, China

Contact Person: Mr. He Yangui Position: Manager Tel: +86-10-67617923 Fax: +86-10-67617393 Email: KEVIN@ELIMEDICAL.COM

1. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
Proposed Device Identification 4.

Trade Name: 1). REDLEAF, Elimedical, and 2) Multiple or Customers' Trade Name Device Name: Latex Surgeon's Gloves (Powdered and Powder Free) Common Name: Surgical Gloves

Classification: I Product Code: Surgeon's Glove - 79KGO Classification Name: surgeon's gloves Regulation Number: 21 CFR 878.4460 Review Panel: General & Plastic Surgery

III - 1

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Intended Use Statement:

A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

1. Predicate Device Identification
  510(k) Number: K063757

Product Name: Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves Manufacturer: SHANGHAI MOTEX HEALTHCARE CO., L TD.

1. Device Description
  The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free) is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is made of natural rubber latex. per standard ASTM D3577-0961, the rubber surgical gloves classification is:

"Type 1 - gloves compounded primarily from natural rubber latex".

The proposed device include Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same colour, creamy white.

The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10% and place in a sterility maintenance package to ensure a shelf life of 3 years.

1. Non-Clinical Test Conclusion
  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 D3577-0981, Standard Specification for Rubber Surgical Gloves.

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.

ASTM D5712-10. Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.

ASTM D6499-07, Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.

ASTM F1929-98 (2004). Standard Test Method for Detecting Seal Leaks in Porous Medical III-2

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Packaging by Dye Penetration.

ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.

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

ISO11137-2: 2006. Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.

1. Substantially Equivalent Comparison Conclusion

ITEM	Proposed Device	Predicate Device (K063757)
Product Code	KGO	Same
Regulation No.	21 CFR 878.4460	Same
Class	1	Same
Intended Use	A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.	Similar
Powdered or Powered free	Powdered, and Powered free	Same
Classification per ASTM D3577	Type 1 - gloves compounded primarily from natural rubber latex	Same
Dimensions	Size 6, 6 $^{1}!/{2}$ , 7, 7 $^{1}!/{2}$ , 8, 8 $^{1}!/_{2}$ , 9Dimensions comply with ASTM D3577	Same
Physical Properties	Comply with ASTM D3577	Same
Freedom from Holes	Comply with ASTM D3577 and ASTM D5151	Same
Powder Content	Comply with ASTM D3577 and ASTM D6124	Same
Protein Content	Comply with ASTM D3577, ASTM D5712 and ASTM D6499	Same
Biocompatibility	Comply with ISO 10993-10	Same
Sterilization	RadiationSAL: 10 $^{-6}$	Same
Label and Labeling	Meet FDA's Requirements	Same

Table III-1 Substantially Equivalent Comparison

Difference in intended use between the proposed and predicate device is discussed in the 510(k) submission documents, it is concluded that the difference will not affectiveness and safety of the proposed device.

The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free), is determined to be Substantially Equivalent (SE) to the predicate device, Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves (K063757), in respect of safety and effectiveness.

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

August 22, 2013

EliMedical Devices (Fujian) Incorporated C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 237-023, Shanghai, China 200237

Re: K130301

Trade/Device Name: Latex Surgeon's Gloves (Powdered and Powder Free) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: KGO Product Code: I Dated: July 5, 2013 Received: August 2, 2013

Dear Ms. Hong:

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. Hong

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/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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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Kwame Ulmer M.S. Acting Division 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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Section II Indications for Use

K130301 510(k) Number:

Device Name: Latex Surgeon's Gloves (Powdered and Powder Free)

Indications for Use:

A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth-Gutala-S
2013.08.22 11:47:44 -04'00'

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _13030

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).