Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary contains no mention of AI or ML.

Therapeutic

No
The device, Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.

Diagnostic

No

Explanation: The device is a glove, which is a barrier intended to prevent contamination. It is not described as being used to diagnose any medical condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the summary describes material properties and performance testing related to the physical characteristics of the gloves, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description clearly states it's a "Class I patient examination glove." This classification aligns with personal protective equipment, not IVDs.
Lack of IVD Characteristics: The description and performance studies focus on physical properties, barrier function, and biocompatibility (skin irritation, sensitization, toxicity). There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Regulatory Classification: The product code "Nitrile - LZA (21CFR880.6250)" refers to patient examination gloves, which are regulated under a different section of the CFR than IVDs.

In summary, the device's function is to provide a physical barrier, which is not the purpose of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

LZA

Device Description

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are available in Orange & Purple color and are powder free and are provided non-sterile. These gloves have a shelf life for 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

Not Found

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)

Non-clinical testing was performed for the subject device.
Performance data for Orange color:

ASTM D6319-2019: Length of gloves, Width of gloves, Thickness of gloves, Physical properties (Tensile strength and Ultimate Elongation).
ASTM D5151-2019: Detection of holes in medical gloves (AQL 2.5).
ASTM D6124-06 (Reapproved 2017): Residual powder on medical gloves.

Performance data for Purple color:

ASTM D6319-2019: Length of gloves, Width of gloves, Thickness of gloves, Physical properties (Tensile strength and Ultimate Elongation).
ASTM D5151-2019: Detection of holes in medical gloves (AQL 2.5).
ASTM D6124-06 (Reapproved 2017): Residual powder on medical gloves.

Biocompatibility data:

ISO 10993-10: Test for Irritation and Skin Sensitization. Result: Not an irritant, not a sensitizer.
ISO 10993-5:2009: Tests for in vitro cytotoxicity. Result: Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern.
ISO 10993-11:2017: Tests for systemic toxicity. Result: Under the conditions of study the device extracts do not pose a systemic toxicity concern.

Key Results: The device meets the ASTM standard D6319-2019 and other relevant standards for physical properties, watertight integrity, powder residue, and biocompatibility, demonstrating substantial equivalence to the predicate device.

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

Length: Min 220mm (XS, S), Min 230 mm (M, L, XL) - specific values measured for each size.
Width: Ranges with +/-10 mm for each size - specific values measured for each size.
Thickness: Palm min 0.05 mm, Finger min 0.05 mm - specific values measured for each size.
Before Aging Tensile Strength: min 14 Mpa - specific values measured for each size.
After Aging Tensile Strength: min 14 Mpa - specific values measured for each size.
Before Aging Ultimate Elongation: 500% Min - specific values measured for each size.
After Aging Ultimate Elongation: 400% Min - specific values measured for each size.
Watertight (1000 ml): Passes AQL-2.5 (Subject Device) vs Passes AQL-1.5 (Predicate Device).
Powder Residue:

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.

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: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

October 21, 2022

JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504

Re: K222349

Trade/Device Name: JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 1, 2022 Received: August 3, 2022

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.

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) 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 (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 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.

Bifeng Qian, M.D., Ph.D. 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) K222349

Device Name

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)

Indications for Use (Describe)

Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3

SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)

510(k) SUMMARY As required by: 21CFR§807.92(c) K222349

510(k Owner's Name	JR Engineering & Medical Technologies (M) Sdn. Bhd.
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
Official 510k Correspondent	Manoj Zacharias, Consultant
Official Contact for JR Engineering & Medical
Technologies (M) Sdn. Bhd
Official 510k Correspondent Firm	Liberty Management Group Ltd
75 Executive Dr. STE114, Aurora, IL 60504 USA
(630) 270-2921 [voice] (815) 986-2632 [fax]
manoj@libertymanagement.us
Date Summary Prepared	19 OCTOBER 2022

APPLICANT INFORMATION ব

B. DEVICE IDENTIFICATION

Name of the device	JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
Product proprietary or trade name	JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
Common or usual name	Exam Gloves
Classification name	Polymer Patient Examination Glove
Device Classification	Class-1
Product Code	LZA
Regulation Number	21 CFR 880.6250
Review Panel	General Hospital

C. PREDICATE DEVICE

Predicate Device	Blue Nitrile Examination Gloves Powder Free
Manufacturer	JR Engineering & Medical Technologies (M)
SDN.BHD.
510(k) Number	K192333
Regulatory Class	1
Product code	LZA

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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)

D. DESCRIPTION OF THEDEVICE:

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are available in Orange & Purple color and are powder free and are provided non-sterile. These gloves have a shelf life for 3 years.

E. INTENDED USE OF THE DEVICE:

JR MEDIC Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

| Characteristics | Standards | Device Performance | | Comparison
Analysis | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| | | Predicate
K192333 | Subject
K222349 | | |
| Name of device | - | Blue Nitrile Examination
Gloves Powder-free | JR MEDIC Nitrile
Examination Gloves Powder
Free (Orange, Purple) | Similar | |
| Manufacturer(s) | - | JR Engineering & Medical
Technologies
(M) SDN.BHD. Malaysia. | JR Engineering & Medical
Technologies
(M) SDN.BHD. Malaysia. | Same | |
| Intended use | - | JR MEDIC Blue Nitrile
Examination Gloves Powder-free
is disposable devices intended
for medical purpose that are wonon the examiner's hand to
prevent contamination between
patient and examiner. | Nitrile Examination Gloves
Powder free is a disposable
device intended for medical
purpose that are worn on the
examiner's hand to prevent
contamination between patient
and examiner. | Similar | |
| Color | - | Blue | Orange, Purple | Different | |
| Texture | - | Finger Texture | Finger texture | Same | |
| Size | ASTM D6319-
2019 | Extra - Small, Small, Medium,
Large, Extra - Large | Extra - Small, Small, Medium,
Large, Extra - Large | Same | |
| Single Use | Medical Glove
Guidance Manual
Labeling | Single Use | Single Use | Same | |
| Shelf Life | Medical Glove
Guidance Manual
Labeling | 3 Years | 3 Years | Same | |
| Characteristics | Standards | Device Performance | | Comparison | |
| | | Predicate
K192333 | Subject
K222349 | Analysis | |
| Color | | Blue | Orange, Purple | Different | |
| Dimensions | ASTM D6319-
2019 | Length min 220mm (XS, S)
min 230 mm (M, L, XL)
Width
70 +/-10 mm (XS)
80 +/-10 mm (S)
95+/-10 mm (M)
110+/-10 mm (L)
120+/-10 mm (XL) | Length min 220mm (XS, S)
min 230 mm (M, L, XL)
70 +/-10 mm (XS)
Width
80 +/-10 mm (S)
95+/-10 mm (M)
110+/-10 mm (L)
120+/-10 mm (XL) | Same | |
| Physical
Properties | ASTM D6319-2019 | Before Aging Tensile
Strength min 14 Mpa
Ultimate Elongation Min
500%
After Aging Tensile
Strength min 14 Mpa
Ultimate Elongation Min
400% | Before Aging Tensile
Strength min 14 Mpa
Ultimate Elongation Min
500%
After Aging Tensile Strength
min 14 Mpa Ultimate
Elongation Min 400% | Same | |
| Thickness | ASTM D6319-2019 | Palm min 0.05 mm
Finger min 0.05 mm | Palm min 0.05 mm
Finger min 0.05 mm | Same | |
| Powder Residue | ASTM D6319-2019 | ≤2 mg/glove | ≤2 mg/glove | Same | |
| Watertight
(1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-2.5 | Similar | |
| Material | ASTM D6319-2019 | Nitrile | Nitrile | Same | |
| Biocompatibility | Primary Skin
Irritation-ISO
10993 - 10:2010
(E) | Under the condition of
study not an irritant | Under the condition of
study not an irritant | Same | |
| | Dermal
Sensitization- ISO
10993-10:2010 -
(E) | Under the conditions of the
study not a sensitizer | Under the conditions of the
study not a sensitizer | Same | |
| | In vitro cytotoxicity
ISO10993-5:2009
(E) | Under the conditions of the
study, cytotoxic | Under the conditions of the
study, cytotoxic | Same | |
| | Acute Systemic
Toxicity Test ISO
10993-11:2017(E) | Under the conditions of study the
device extracts do not pose a
systemic toxicity concern | Under the conditions of study
the device extracts do not pose a
systemic toxicity concern | Same | |
| Test Method | Purpose | Acceptance
Criteria | Result | | |
| | | | | | |
| ASTM D6319-2019
Standard Specification for
Nitrile Examination Gloves for
Medical Application | To determine the
length of the gloves | Min 220mm (XS, S)
Min 230 mm (M, L, XL) | X-Small:- 236 mm
Small:- 236 mm
Medium:- 238 mm
Large:- 238 mm
X-Large:- 240 mm | | |
| ASTM D6319-2019
Standard Specification for
Nitrile Examination Gloves for
Medical Application | To determine the
width of the gloves | X-Small:- 70+/-10 mm
Small:- 80+/-10 mm
Medium:- 95+/-10mm
Large:- 110+/-10 mm
X-Large:- 120+/-10 mm | X-Small- 74 mm
Small:- 84 mm
Medium:- 94 mm
Large:- 104 mm
X-Large:- 114 mm | | |
| ASTM D6319-2019
Standard Specification for Nitrile
Examination Gloves for
Medical Application | To determine the
thickness of the
gloves | Palm 0.05 mm min
Finger 0.05 mm min
for all sizes | Size
X-Small
Small
Medium
Large
X-Large | Palm
0.18mm
0.18mm
0.18mm
0.18mm
0.18mm | Finger
0.20mm
0.20mm
0.20mm
0.20mm
0.20mm |
| ASTM D6319-2019
Standard Specification for
Examination Gloves for
Medical Application | To determine the
physical properties -
Tensile strength | Before Aging Tensile
Strength 14Mpa Min
for all sizes

After Aging
Tensile Strength
14Mpa Min for all
sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
Aging
22.77 Mpa
22.80 Mpa
24.46 Mpa
24.51 Mpa
24.59 Mpa | After
Aging
20.50 Mpa
20.69 Mpa
21.28 Mpa
21.34 Mpa
21.36 Mpa |
| | To determine the
physical properties -
Ultimate Elongation | Before Aging
Ultimate Elongation
500% Min for all
sizes

Before Aging
Ultimate Elongation
400% Min for all
sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
Aging
885%
886%
888%
891%
892% | After
Aging
760%
764%
767%
769%
772% |

F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)

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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-2019.

G.NON-CLINICAL TESTING SUMMARY OF JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE

PERFORMANCE DATA – ORANGE COLOR

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JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)

Test Method	Purpose	Acceptance Criteria
ASTM D6319-2019
Standard Specification for
Nitrile Examination Gloves for
Medical Application	To determine the
length of the gloves	Min 220mm (XS, S)
Min 230 mm (M, L, XL)	X-Small:- 245 mm
Small:- 245 mm
Medium:- 246 mm
Large:- 248 mm
X-Large:- 248 mm
ASTM D6319-2019
Standard Specification for
Nitrile Examination Gloves for
Medical Application	To determine the
width of the gloves	X-Small:- 70+/-10 mm
Small:- 80+/-10 mm
Medium:- 95+/-10mm
Large:- 110+/-10 mm
X-Large:- 120+/-10 mm	X-Small:- 76 mm
Small:- 85 mm
Medium:- 95 mm
Large:- 104 mm
X-Large:- 115 mm
ASTM D6319-2019
Standard Specification for
Nitrile Examination Gloves
for Medical Application	To determine the
thickness of the
gloves	Palm 0.05 mm min
Finger 0.05 mm min
for all sizes	Size Palm Finger
X-Small 0.18mm 0.21mm
Small 0.18mm 0.21mm
Medium 0.18mm 0.21mm
Large 0.18mm 0.21mm
X-Large 0.18mm 0.21mm
ASTM D6319-2019
Standard Specification for
Nitrile Examination Gloves
for Medical Application	To determine the
physical properties-
Tensile strength	Before Aging
Tensile Strength 14Mpa
Min for all sizes
After Aging
Tensile Strength 14Mpa
Min for all sizes	Size Before Aging After Ageing
X-Small 22.78 Mpa 20.48 Mpa
Small 22.82 Mpa 20.67 Mpa
Medium 24.47 Mpa 21.30 Mpa
Large 24.52 Mpa 21.35 Mpa
X-Large 24.58 Mpa 21.36 Mpa
	To determine the
Physical properties-
Ultimate Elongation	Before Aging
Ultimate Elongation
500% Min for all sizes
After Aging
Ultimate Elongation
400% Min for all sizes	Size Before Aging After Aging
X-Small 884% 759%
Small 885% 763%
Medium 887% 766%
Large 892% 768%
X-Large 893% 772%
ASTM D5151-2019
Standard Test Method for
Detection of Holes in Medical
Gloves	To determine the holes
in the gloves	AQL 2.5	Gloves Passes AQL 2.5
ASTM D6124-06
(Reapproved 2017) Standard
Test Method for Residual
Powder on Medical Gloves	To determine the
residual powder in
the gloves	2 Mg/Glove Max	Size Residual Powder Content
X-Small 0.16 mg/glove
Small 0.16 mg/glove
Medium 0.16 mg/glove
Large 0.16 mg/glove
X-Large 0.16 mg/glove

PERFORMANCE DATA-PURPLE COLOR

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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)

BIOCOMPATIBILITY DATA

| Test Method | Purpose | Acceptance
Criteria | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10
Biological Evaluation of
Medical Devices Test for
Irritation and Skin Sensitization.
Test done for irritation. | To determine the potential of
the material under test to
produce dermal irritation in
Rabbits | Under the condition
of
study
not
an
irritant | Under the condition of
study not an irritant |
| ISO 10993-10
Biological Evaluation of Medical
Devices Test for Irritation and
Skin Sensitization. Test done Skin
sensitization. | To
the
skin
determine
sensitization potential of the
material both in terms of
induction and elicitation in
Guinea Pig. | Under the conditions
of the study not a
sensitizer | Under the conditions of
the study not a sensitizer |
| ISO 10993-5:2009
Biological evaluation of medical
devices - part 5, tests for in vitro
cytotoxicity. | To evaluate the in vitro
cytotoxic potential of the test
item (both inner and outer
surface) Extracts in L-929
fibroblasts
cells
mouse
using elution method. | Under the conditions
of study non cytotoxic | Under the conditions of
the study, cytotoxic.
Additional testing was
performed to determine
if this was a systemic
toxicity concern. |
| ISO 10993-11:2017
Biological evaluation of medical
devices - part 11, tests for
systemic toxicity. | To
determine
the
acute
systemic toxicity potential of
the test item extracts (both
inside and outer surfaces) in
Swiss Albino mice. | Under the conditions
of study the device
extracts do not pose a
systemic toxicity
concern | Under the conditions of
study the device
extracts do not pose a
systemic toxicity
concern |

H. Clinical Testing Summary

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

I. CONCLUSION

The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) submission, JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192333.