Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterilization of a latex surgeon's glove, with no mention of AI or ML.

Therapeutic

No.
The device is a surgeon's glove, intended to protect a surgical wound from contamination, which is a barrier function rather than a therapeutic one.

Diagnostic

No

This device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made of natural rubber latex, intended to be worn by operating room personnel. It describes material properties, sterilization methods, and physical characteristics, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier function for infection control, not a diagnostic test performed on samples taken from the body.
Device Description: The description focuses on the physical properties of the glove (material, sterilization, size, etc.) and its function as a protective barrier. There is no mention of analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.

The provided information clearly describes a medical device used for protection during surgery, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KGO

Device Description

The proposed device, Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein 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, as per standard ASTM D35 77 -09

The classification is: Type I - gloves compounded primarily from natural rubber latex".

The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes.

All variants share the same color, creamy, white.

The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 +and place in a sterility maintenance package to ensure a shelf life of 3 years.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

ASTM D3577-09:- Standard Specification for Rubber Surgical Gloves.

ASTM D 5151-2011:-Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-2011:- Standard Test Method for Residual Powder on Medical Gloves.

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

ASTM D6499-12:-Standard Test Method for the Immunological Measurement of Antigenic Proteinin Natural Rubber and Its Products.

ASTM F 1929-2004:- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.

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

1S01137-2: 2013. Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.

ISO 10993-7:2008:-Biological evaluation of medical devices -: Ethylene oxide sterilization residuals

ISO 11135-1:2007 :- Sterilization of healthcare products -- Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The subject device complied with the ASTM D3577-09 standard for length, width, finger thickness, palm thickness, cuff thickness, tensile strength (before and after aging), ultimate elongation (before and after aging), stress at 500% before aging, and pinhole AQL (before and after aging).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K151114, K130450

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

January 8, 2018

Beta Healthcare Products Pvt. Ltd. % Manoj Zacharias President Liberty Management Group Ltd 75 Executive Dr., Ste 114 Aurora, Illinois 60504

Re: K172942

Trade/Device Name: Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: November 29, 2017 Received: December 5, 2017

Dear Manoj Zacharias:

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.

1

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); 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.

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.

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.

Tina Kiang -S

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

2

Indications for Use

510(k) Number (if known) K172942

Device Name

Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein)

Indications for Use (Describe)

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.

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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K172942

PAGE NO -1

510K SUMMARY as required by: 21CFR § 807.92 A. APPLICANT INFORMATION

1.	Submitter Name	Beta Healthcare Products Pvt.Ltd.
	Date Submitted	November 29, 2017
	Address	Plot No 21B,
Cochin Special Economic Zone,
Kakkanad,Kochi-682037.
Kerala, India.
	Phone	+91 484 2413389 , 2413390
	Fax	+91 484 2413341
	E-mail	betahealthcare@gmail.com
	Contact Person	Boney Moolayil
	Designation	Director
	Contact Number	+91 974700797
	Contact Email	betahealthcare@gmail.com

B. US AGENT & CONTACT PERSON INFORMATION

17	US agent & contact person name	Manoj Zacharias
18	Address	Liberty Management Group Ltd.
75 Executive Dr, STE 114, Aurora, IL-60504, USA.
19	Phone	(630) 270-2921
20	Fax	(815) 986-2632
21	E-mail	manoj@libertymanagement.us

C. DEVICE IDENTIFICATION

Common Name	Surgeon's Glove
Device Name	Surgeon's Glove powder free
Product proprietary or trade name	Pristeen (Latex Surgeon's Gloves
Powder Free, Polymer coated with
protein content labeling claim of 50
µg/dm² or less per glove of
extractable protein)
Classification name	Surgeon's Glove
Device Classification	1
Product Code	KGO
Regulation Number	21 CFR 878.4460
Review Panel	Gen & Plastic Surgery

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K172942

PAGE NO -2

D.PREDICATE DEVICE INFORMATION

Sl.No	Name of devices	510k Number
Predicate device-1	Medismart+ Latex Surgeon's
Glove powder free-polymer
coated with protein content
labeling claim of 50 $ \u00b5g $ /dm² or
less per glove of extractable
protein	K151114	St.Marys Rubbers Pvt.Ltd.
Koovappally P.O,
Kanjirappally, Kottayam
District, Kerala State, India-
686518
Predicate device-2	SURGTEX Latex Surgeon's
Glove powder free-polymer
coated with protein content
labeling claim of 50 $ \u00b5g $ /dm² or
less per glove of extractable
protein	K130450	Purna Bina SDN BHD
Plo 5, Jalan Mahsuri, 7.5km,
Jalan Mersing,
Kluang Industrial Area
Kluang, Johor 86000

E. DESCRIPTION OF THE DEVICE

The proposed device, Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein 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, as per standard ASTM D35 77 -09

The classification is: Type I - gloves compounded primarily from natural rubber latex".

The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes.

All variants share the same color, creamy, white.

The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 +and place in a sterility maintenance package to ensure a shelf life of 3 years.

F. INDICATIONS FOR 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.

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K172942

PAGE NO - 3

G. NON-CLINICAL TEST CONCLUSION