Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterility of a latex surgical glove, with no mention of AI or ML technologies.

Therapeutic

No
The device is a surgeon's glove intended to protect a surgical wound from contamination, not to treat or alleviate a disease or condition.

Diagnostic

No

The device, JR Medic Latex Surgeon's Gloves, is a protective barrier intended to prevent contamination during surgery, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (latex surgeon's gloves) and the performance studies focus on physical properties and biological compatibility, not software performance.

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 physical barrier function, not a diagnostic test performed on a sample taken from the body.
Device Description: The description focuses on the physical properties and manufacturing of a glove. It does not describe any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls

The device described is a Class II medical device (based on the predicate device K172942, which is a Class II device) intended for surgical use as a barrier. It falls under the category of surgical gloves, which are not IVDs.

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

KGO

Device Description

The proposed device, JR Medic Latex Surgeon's Gloves Sterile Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile 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(2015), Standard Specification for Rubber Surgical Gloves.

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 using Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained 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 or acceptance criteria found in the test method or standard. The test results demonstrated that the proposed device met design specifications or acceptance criteria with the following standards:

ASTM D3577-09(15):- Standard Specification for Rubber Surgical Gloves.

ASTM D 5151-06 (2015):-Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (2017):- Standard Test Method for Residual Powder on Medical Gloves.

ASTM D5712-15:-Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.

ASTM D6499-18:-Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.

ASTM F 1929-2015:- Standard Test Method for Detecting Seal Leaks in Porous Meckaging by Dye Penetration.

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

ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity and Biological Tests

USP 41 Pyrogen Test

ISO 11137-1-2006/ (R) 2010 - validation of sterilization process

ISO 11137-2:2013, sterilization of health care products - radiation - part 2: establishing the sterilization dose

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

Criteria	Specification as per ASTMD3577-09, Standard Specification for Rubber Surgical Gloves	Average value of subject device	Compliance with the ASTMD 3577-09, Standard Specification for Rubber Surgical Gloves
Length:
Size 6	Min 265mm	306mm	Yes
Size 6'/2	Min 265mm	306mm	Yes
Size 7	Min 265mm	305mm	Yes
Size 7'/2	Min 265mm	305mm	Yes
Size 8	Min 265mm	305mm	Yes
Size 8'/2	Min 265mm	305mm	Yes
Size 9	Min 265mm	305mm	Yes
Width:
Size 6	76+/-6mm	78mm	Yes
Size 6'⁄2	83+/-6mm	85mm	Yes
Size 7	89+/-6mm	88mm	Yes
Size 7'⁄2	95+/-6mm	97mm	Yes
Size 8	102+/-6mm	103mm	Yes
Size 8'⁄2	108+/-6mm	110mm	Yes
Size 9	114+/-6mm	116mm	Yes
Finger Thickness (All sizes)	Min 0.10mm	0.21mm	Yes
Palm Thickness (All sizes)	Min 0.10mm	0.18mm	Yes
Cuff Thickness (All sizes)	Min 0.10mm	0.11mm	Yes
Tensile Strength:
Before aging (All sizes)	24Mpa minimum	26.0Mpa	Yes
After aging@ 70°±2C for 166±2 hr (All sizes)	18Mpa minimum	22.0Mpa	Yes
Ultimate Elongation:
Before aging (All sizes)	750% minimum	860%	Yes
After aging@ 70°±2C for 166±2 hr (All sizes)	560% minimum	725%	Yes
Stress at 500% before ageing (All sizes)	5.5 MPa Max	2.7 Mpa	Yes
Pinhole AQL:
Before aging (All sizes)	Max 1.5	1.0	Yes
After aging@ 70°C for 7 days (All sizes)	Max 1.5	1.0	Yes
Powder content	Pyrogen Test	Non pyrogenic	Non pyrogenic

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.

K172942

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.

K151114

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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

March 10, 2020

JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr, STE 114 Aurora, Illinois 60504

Re: K192328

Trade/Device Name: JR MEDIK Latex Surgeon's Gloves Sterile Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: February 12, 2020 Received: February 14, 2020

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. 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.

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

1

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K192328

Device Name

JR Medic Latex Surgeon's Gloves Sterile Powder Free

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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510K SUMMARY

K192328

as required by: 21 CFR § 807.92

A. APPLICANT INFORMATION

| Submitter Name | JR Engineering & Medical Technologies (M)
SDN.BHD. |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Submitted | 24th Nov 2019 |
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1 & 3, Jalan Zurah 3A/1
Pusat Perindustrian 2, 44200 Rasa,
Hulu Selangor, Selangor Darul Ehsan, Malaysia. |
| Phone | +603-60572081 |
| Fax | +603-60572181 |
| E-mail | ganeshjrmt@gmail.com |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | +6012 224 6677 |
| Contact Email | ganeshjrmt@gmail.com |

B. US AGENT & CONTACT PERSON INFORMATION

US agent & contact person name	Manoj Zacharias
Address	Liberty Management Group Ltd.
2871, Coastal Dr. Aurora, IL-60503, USA
Phone	(630) 270-2921
Fax	(815) 986-2632
E-mail	manoj@libertymanagement.us

C. DEVICE IDENTIFICATION

Common Name	Surgeon's Gloves
Device Name	Surgeon's Gloves powder free
Product proprietary
or trade name	JR MEDIC LATEX SURGEON'S GLOVES STERILE POWDER FREE
Classification name	Surgeon's Gloves
Device Classification	I
Product Code	KGO
Regulation Number	21 CFR 878.4460
Review Panel	General Hospital

4

D.PREDICATE DEVICE INFORMATION

Device	Name of device	510k Number
Predicate
device	Pristeen Latex Surgeon's Gloves
powder free with protein content
labeling claim of 50 $\mu g/dm^2$ or less
per glove of extractable protein	K172942	Beta Healthcare Products
Pvt.Ltd, Plot No 21B,
Cochin Special Econmic
Zone, Kakkanad, Kerala,
India-682037.
Reference
device	Medismart+ Latex Surgeon's
Gloves powder with protein content
labeling claim of 50
$\mu g/dm^2$ or less per glove of
extractable protein	K151114	St.Marys Rubbers Pvt.Ltd,
Koovappally P.O,
Kanjirappally, Kottayam
District, Kerala State,
India-686518

E. DESCRIPTION OF THE DEVICE

The proposed device, JR Medic Latex Surgeon's Gloves Sterile Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile 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(2015), Standard Specification for Rubber Surgical Gloves.

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 using Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.

F. INDICATION 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.

G. TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

a. General Characteristics Comparison

| Characteristic | Subject device
K192328 | Predicate device
K172942 | comparison |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | I | I | 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 | 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 |

5

| Powdered or

Powder free	powered free	powered free	Same
Compounding
Classification	Type I - gloves compounded
primarily from natural rubber
latex	Type I - gloves compounded
primarily from natural rubber latex	Same
Sterilization	Radiation,
SAL- 10-6	ETO/as well as
Radiation, SAL- 10-6	Different
Labeling	Meet FDA's label
Requirements	Meet FDA's label
Requirements	Same
Special label
claim	Protein content labeling claim of
50
µg/dm² or less	Protein content labeling claim of
50
µg/dm² or less	Same
Type of use	Over the counter use	Over the counter use	Same

b. Technological Characteristics Comparison

| Specification and physical properties per ASTM
D3577- 09(Reapproved 2015), Standard Specification
for Rubber Surgical Gloves. | Subject
device
K192328 | Predicate
device
K172942 | Remarks | |
|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------|---------|---------|
| Dimensions Length: Min 265 mm | 300 mm | 282 mm | Similar | |
| Width | | | | |
| Size | 6.0(76+/-6mm) | 78mm | 78mm | Similar |
| | 6.5(83+/-6mm) | 85mm | 84mm | |
| | 7.0(89+/-6mm) | 88mm | 91mm | |
| | 7.5(95+/-6mm) | 97mm | 97mm | |
| | 8.0(102+/-6mm) | 103mm | 103mm | |
| | 8.5(108+/-6mm) | 110mm | 109mm | |
| | 9(114+/-6mm) | 116mm | 115mm | |
| Thickness for all sizes | | | | |
| Cuff, Palm, Finger Tip Min 0.10 mm | Cuff- 0.11mm | Cuff- 0.13mm | Similar | |
| | Palm- 0.18mm | Palm-0.16mm | | |
| | Finger Tip-
0.21mm | Finger Tip-
0.18mm | | |
| Physical Properties Before Ageing -for all sizes | | | | |
| Tensile Strength 24Mpa minimum | 26.0Mpa | 28.0Mpa | Similar | |
| | Ultimate Elongation 750% minimum | 860% | 920% | |
| | Stress at 500% 5.5 MPa Max | 2.7 Mpa | 3 Mpa | |
| Physical Properties After Ageing -for all sizes | | | | |
| Tensile Strength 18Mpa minimum | 22.0Mpa | 24.0Mpa | Similar | |
| | Ultimate Elongation 560% minimum | 725% | 750% | |
| | Freedom from Holes AQL 1.5, AST M D5151-06,
(2015), Standard Test Method for Detection of Holes | AQL 1.0 | AQL 1.0 | Similar |

6

in Medical Gloves
Powder content Pyrogen Test	Non pyrogenic	Non pyrogenic	same

H. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

| Sl.No | Criteria | Specification as per
ASTMD3577-09,
Standard
Specification for
Rubber Surgical
Gloves | Average value of
subject device | Compliance with the
ASTMD 3577-09,
Standard Specification
for Rubber Surgical
Gloves |
|-------|-----------|-----------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------|
| 1 | Length | | | |
| | Size 6 | Min 265mm | 306mm | Yes |
| | Size 6'/2 | Min 265mm | 306mm | Yes |
| | Size 7 | Min 265mm | 305mm | Yes |
| | Size 7'/2 | Min 265mm | 305mm | Yes |
| | Size 8 | Min 265mm | 305mm | Yes |
| | Size 8'/2 | Min 265mm | 305mm | Yes |
| | Size 9 | Min 265mm | 305mm | Yes |

7

2	Width
	Size 6	76+/-6mm	78mm	Yes
	Size 6'⁄2	83+/-6mm	85mm	Yes
	Size 7	89+/-6mm	88mm	Yes
	Size 7'⁄2	95+/-6mm	97mm	Yes
	Size 8	102+/-6mm	103mm	Yes
	Size 8'⁄2	108+/-6mm	110mm	Yes
	Size 9	114+/-6mm	116mm	Yes
3	Finger Thickness
(All sizes)	Min 0.10mm	0.21mm	Yes
4	Palm Thickness
(All sizes)	Min 0.10mm	0.18mm	Yes
5	Cuff Thickness
(All sizes)	Min 0.10mm	0.11mm	Yes

| SL.NO | Criteria | Specification as per
ASTMD3577-09
Standard
Specification for
Rubber Surgical
Gloves | Average value of
subject device | Whether subject device
complied with the
ASTMD3577 -09,
Standard Specification
for Rubber Surgical
Gloves |
|-------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 6 | Tensile Strength | | | |
| | Before aging
(All sizes) | 24Mpa minimum | 26.0Mpa | Yes |
| | After aging@
70°±2C for
166±2 hr
(All sizes) | 18Mpa minimum | 22.0Mpa | Yes |
| 7 | Ultimate Elongation | | | |
| | Before aging
(All sizes) | 750% minimum | 860% | Yes |

8

| | After aging@
70°±2C for
166±2 hr
(All sizes) | 560% minimum | 725% | Yes |
|---|-------------------------------------------------------|--------------|---------|-----|
| 8 | Stress at 500%
before ageing
(All sizes) | 5.5 MPa Max | 2.7 Mpa | Yes |
| 9 | Pinhole AQL | | | |
| | Before aging
(All sizes) | Max 1.5 | 1.0 | Yes |
| | After aging@
70°C for 7 days
(All sizes) | Max 1.5 | 1.0 | Yes |