K Number
K221157
Device Name
JR Medic
Date Cleared
2022-08-30

(131 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs. The tested chemotherapy drugs and their breakthrough detection times are as follows: | Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time | |-----------------------------------------------|-------------------------------------| | Carmustine (BCNU) (3.3 mg/ml) | 23.8 Minutes | | Carboplatin (10 mg/ml) | >240 Minutes | | Cisplatin (1 mg/ml) | >240 Minutes | | Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes | | Dacarbazine (10.0 mg/ml) | >240 Minutes | | Doxorubicin HCl (2 mg/ml) | >240 Minutes | | Etoposide (20 mg/ml) | >240 Minutes | | Fluorouracil (50 mg/ml) | >240 Minutes | | Ifosfamide (50 mg/ml) | >240 Minutes | | Methotrexate (25 mg/ml) | >240 Minutes | | Mitomycin C (0.5 mg/ml) | >240 Minutes | | Mitoxantrone (2 mg/ml) | >240 Minutes | | Paclitaxel (6 mg/ml) | >240 Minutes | | Thiotepa (10 mg/ml) | 24.1 Minutes | | Vincristine Sulfate (1 mg/ml) | >240 Minutes | Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes Thiotepa (10 mg/ml) 24.1 Minutes Warning: Do not use with Carmustine or Thiotepa.
Device Description
The subject device in 510(K) notification K221157 is JR Medic Blue Latex Examination Powder Free Gloves tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from Natural Rubber Latex, blue color, powder free and non-sterile (as per 21CFR 880.6250, class I). The subject device meets all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).
More Information

Not Found

No
The device is a physical examination glove and the summary describes its material properties and testing against chemotherapy drugs, with no mention of AI or ML.

No
The device is described as an examination glove intended to prevent contamination between patient and examiner, and for protection against chemotherapy drugs, not for treating a disease or condition.

No.

The device is a medical glove intended to prevent contamination between patients and examiners, and it has been tested for use with chemotherapy drugs. Its purpose is protective, not diagnostic.

No

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

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

Here's why:

  • Intended Use: The intended use clearly states the device is a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical examinations.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such testing.
  • Device Description: The device is described as a "patient examination glove made from Natural Rubber Latex." This aligns with its intended use as a barrier device, not an IVD.
  • Performance Studies: The performance studies focus on the physical properties of the glove (dimensions, watertightness, etc.), biocompatibility, and resistance to chemotherapy drug permeation. These are relevant to a protective barrier device, not an IVD.

The testing for use with chemotherapy drugs is an additional performance characteristic of the glove, indicating its suitability for use in environments where these drugs are handled. It does not change the fundamental nature of the device from a protective barrier to an IVD.

N/A

Intended Use / Indications for Use

JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Tested Chemotherapy Drug Name & ConcentrationMinimum Breakthrough Detection Time
Carmustine (BCNU) (3.3 mg/ml)23.8 Minutes
Carboplatin (10 mg/ml)>240 Minutes
Cisplatin (1 mg/ml)>240 Minutes
Cyclophosphamide (Cytoxan) (20 mg/ml)>240 Minutes
Dacarbazine (10.0 mg/ml)>240 Minutes
Doxorubicin HCl (2 mg/ml)>240 Minutes
Etoposide (20 mg/ml)>240 Minutes
Fluorouracil (50 mg/ml)>240 Minutes
Ifosfamide (50 mg/ml)>240 Minutes
Methotrexate (25 mg/ml)>240 Minutes
Mitomycin C (0.5 mg/ml)>240 Minutes
Mitoxantrone (2 mg/ml)>240 Minutes
Paclitaxel (6 mg/ml)>240 Minutes
Thiotepa (10 mg/ml)24.1 Minutes
Vincristine Sulfate (1 mg/ml)>240 Minutes

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes Thiotepa (10 mg/ml) 24.1 Minutes

Warning: Do not use with Carmustine or Thiotepa.

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

LYY, LZC, OPJ

Device Description

The subject device in 510(K) notification K221157 is JR Medic Blue Latex Examination Powder Free Gloves tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from Natural Rubber Latex, blue color, powder free and non-sterile (as per 21CFR 880.6250, class I).
The subject device meets all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

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 performance data was summarized, including tests for:

  • Length, width, and thickness of gloves per ASTM D3578-2019.
  • Physical properties (tensile strength, ultimate elongation, stress at 500% elongation) before and after aging per ASTM D3578-2019.
  • Detection of holes per ASTM D5151-2019 (AQL 1.5 achieved).
  • Residual powder per ASTM D6124-06 (Reapproved 2017) (e.g., 0.21 mg/glove for small size).
  • Extractable protein per ASTM D 5712-95 (Reapproved 2010) (e.g., 43.12 µg/ dm² for small size).
  • Biocompatibility tests: Primary Skin Irritation, Dermal Sensitization (ISO 10993-10:2010), in vitro cytotoxicity (ISO 10993-5:2009), Acute systemic toxicity, Material Mediated Pyrogenicity (ISO 10993-11:2017 / USP 41). Key results indicate non-irritating, non-sensitizing, cytotoxic (ISO 10993-5), non-systemic toxicity, and non-pyrogenic.
  • Chemotherapy drug permeation testing per ASTM D6978-05 (2019). Breakthrough detection times are listed for 15 chemotherapy drugs, with most showing >240 minutes, but Carmustine (BCNU) at 23.8 minutes and Thiotepa at 24.1 minutes.

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

  • Length: Small 304 mm, Medium 304 mm, Large 305 mm, X-Large 305 mm (Min accepted 230 mm for all sizes)
  • Width: Small 84 mm, Medium 94 mm, Large 105 mm, X-Large 114 mm (Ranges specified)
  • Thickness: Palm 0.31mm, Finger 0.38mm for all sizes (Min accepted 0.08 mm for both)
  • Before Ageing Tensile Strength: Small 33.16 Mpa, Medium 32.93 Mpa, Large 32.43 Mpa, X-Large 32.36 Mpa (Min accepted 18 Mpa)
  • After Ageing Tensile Strength: Small 30.78 Mpa, Medium 30.73 Mpa, Large 30.23 Mpa, X-Large 30.16 Mpa (Min accepted 14 Mpa)
  • Before Ageing Ultimate Elongation: Small 1320%, Medium 1288%, Large 1376%, X-Large 1200% (Min accepted 650%)
  • After Ageing Ultimate Elongation: Small 1066%, Medium 1105%, Large 1225%, X-Large 1041% (Min accepted 500%)
  • Stress at 500% Elongation: Medium 5.1 Mpa, Large 5.2 Mpa, X-Large 5.2 Mpa (Max accepted 5.5 Mpa)
  • Watertight (1000 ml): Passes AQL 1.5 (Predicate passed AQL 2.5)
  • Residual Powder Content: Small 0.21 mg/glove, Medium 0.22 mg/glove, Large 0.22 mg/glove, X-Large 0.22 mg/glove (Max accepted 2 mg/Glove)
  • Extractable Protein content: Small 43.12 µg/ dm², Medium 41.16 µg/ dm², Large 42.06 µg/ dm², X-Large 46.24 µg/ dm² (Max accepted 200 µg/ dm²)
  • Biocompatibility: Non-irritant (Primary Skin Irritation), Not a sensitizer (Dermal Sensitization), Cytotoxic (In vitro cytotoxicity), No systemic toxicity (Acute systemic toxicity), Non-pyrogenic (Material Mediated Pyrogenicity).
  • Chemotherapy Drugs Tested (Minimum Breakthrough Detection Time):
    • Carmustine (BCNU) (3.3 mg/ml): 23.8 Minutes
    • Carboplatin (10 mg/ml): >240 Minutes
    • Cisplatin (1 mg/ml): >240 Minutes
    • Cyclophosphamide (Cytoxan) (20 mg/ml): >240 Minutes
    • Dacarbazine (10.0 mg/ml): >240 Minutes
    • Doxorubicin HCl (2 mg/ml): >240 Minutes
    • Etoposide (20 mg/ml): >240 Minutes
    • Fluorouracil (50 mg/ml): >240 Minutes
    • Ifosfamide (50 mg/ml): >240 Minutes
    • Methotrexate (25 mg/ml): >240 Minutes
    • Mitomycin C (0.5 mg/ml): >240 Minutes
    • Mitoxantrone (2 mg/ml): >240 Minutes
    • Paclitaxel (6 mg/ml): >240 Minutes
    • Thiotepa (10 mg/ml): 24.1 Minutes
    • Vincristine Sulfate (1 mg/ml): >240 Minutes

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.

K121926

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

§ 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.

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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 30, 2022

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

Re: K221157

Trade/Device Name: JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY, LZC, OPJ Dated: August 4. 2022 Received: August 4, 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); medical device reporting (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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

2

Indications for Use

510(k) Number (if known) K221157

Device Name

JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs

Indications for Use (Describe)

JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Tested Chemotherapy Drug Name & ConcentrationMinimum Breakthrough Detection Time
Carmustine (BCNU) (3.3 mg/ml)23.8 Minutes
Carboplatin (10 mg/ml)>240 Minutes
Cisplatin (1 mg/ml)>240 Minutes
Cyclophosphamide (Cytoxan) (20 mg/ml)>240 Minutes
Dacarbazine (10.0 mg/ml)>240 Minutes
Doxorubicin HCl (2 mg/ml)>240 Minutes
Etoposide (20 mg/ml)>240 Minutes
Fluorouracil (50 mg/ml)>240 Minutes
Ifosfamide (50 mg/ml)>240 Minutes
Methotrexate (25 mg/ml)>240 Minutes
Mitomycin C (0.5 mg/ml)>240 Minutes
Mitoxantrone (2 mg/ml)>240 Minutes
Paclitaxel (6 mg/ml)>240 Minutes
Thiotepa (10 mg/ml)24.1 Minutes
Vincristine Sulfate (1 mg/ml)>240 Minutes

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes Thiotepa (10 mg/ml) 24.1 Minutes

Warning: Do not use with Carmustine or Thiotepa.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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4

510K SUMMARY K221157

As required by 21CFR§807.92(c)

A. APPLICANT INFORMATION

510(K) Owner's NameJR Engineering & Medical Technologies (M) SDN.BHD.
AddressLot 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-mailganeshjrmt@gmail.com
Contact PersonMr. Ganesan Subramaniam
DesignationManaging Director
Contact Number+6012 224 6677
Contact Emailganeshjrmt@gmail.com
Date SubmittedAugust 25, 2022

B. DEVICE IDENTIFICATION

| Name of the device | JR Medic Blue Latex Examination Powder Free Gloves
Tested for use with Chemotherapy drugs. |
|-----------------------------------|-----------------------------------------------------------------------------------------------|
| Product proprietary or trade name | JR MEDIC |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty |
| Device Classification | Class-1 |
| Product Code | LYY, LZC, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

C. PREDICATE DEVICE

| Predicate Device | Textured, Blue, Latex Powder Free Examination Gloves,
Tested For Use With Chemotherapy Drugs With Protein
Labeling Claim (50µg/dm² or Less of Water Soluble
Protein) |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510( K) Number | K121926 |
| Regulatory Class | 1 |
| Product code | LZC |

D. DESCRIPTION OF THE DEVICE:

The subject device in 510(K) notification K221157 is JR Medic Blue Latex Examination Powder Free Gloves tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from Natural Rubber Latex, blue color, powder free and non-sterile (as per 21CFR 880.6250, class I).

5

The subject device meets all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).

E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:

JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs

| Tested Chemotherapy Drug Name &
Concentration | Minimum Breakthrough Detection
Time (Minutes) |
|--------------------------------------------------|--------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 23.8 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 24.1 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |

The tested chemotherapy drugs and their breakthrough detection times are as follows:

6

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

CHARACTERSTICSSTANDARDSDEVICE PERFORMANCEComparison
PREDICATEPROPOSED
DEVICE
510(K) Number-K121926K221157
Name of device-Textured, Blue,
Latex Powder
Free Examination
Gloves, Tested
For Use With
Chemotherapy
Drugs With
Protein Labeling
Claim ( $50µg/dm²$
or Less of Water
Soluble Protein)JR Medic
Blue Latex
Examination
Powder Free
Gloves Tested for
Use with
Chemotherapy
DrugsSimilar
Product Code-LZCLYY, LZCSame
Intended use / Indications
for Use-The 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.
In addition, these
gloves were
tested for use
with
chemotherapy
drugs in
accordance with
ASTM D6978-05
Standard Practice
for Assessment
of MedicalJR Medic Blue
Latex
Examination
Powder Free
Gloves Tested
for use with
Chemotherapy
drugs are
disposable
device intended
for medical
purpose that is
worn on the
examiner's hand
to prevent
contamination
between patient
and examiner.
Additionally,
the gloves were
tested for use
with
chemotherapy
drugs in
accordance withSimilar

7

| Gloves to | ASTM D6978-
05 (2019)
Standard
Practice for |

-----------------------------------------------------------------
CHARACTERSTICSSTANDARDSDEVICE PERFORMANCEComparison
PREDICATE
K121926PROPOSED
DEVICE
K221157
Permeation of
Chemotherapy
DrugsAssessment of
Medical Glove to
Permeation by
Chemotherapy
Drugs.
Regulation Number-21 CFR 880.625021 CFR 880.6250Same
Material-Natural LatexNatural LatexSame
Color-BlueBlueSame
Texture-Finger TextureFinger textureSame
SizeASTM D3578-
2019Small, Medium,
Large, Extra
LargeSmall, Medium,
Large, Extra LargeSame
Single UseMedical Glove
Guidance
Manual
  • Labeling | Single Use | Single Use | Same |
    | Sterile/nonsterile | - | Nonsterile | Nonsterile | Same |
    | Dimensions | ASTM D3578-
    2019 | Length: Small-
    Min 220 mm &
    Medium, Large
    & Extra-large-
    Min 230 mm
    Width Min 95+/-
    10 mm( Medium
    Size) | Length > 230 mm
    Width Min 95+/-10
    mm(for medium
    size) | Similar |
    | Physical Properties | ASTM D3578-
    2019 | Before Ageing
    Tensile Strength
    min 18 Mpa
    Ultimate
    Elongation
    Min 650%
    After Ageing
    Tensile Strength
    min 14 Mpa
    Ultimate
    Elongation
    Min 500% | Before Ageing
    Tensile Strength

18 Mpa
Ultimate
Elongation
650%
After Ageing
Tensile Strength
14 Mpa
Ultimate
Elongation
500% | Similar |
| Thickness | ASTM D3578-
2019 | Palm min 0.08
mm | Palm > 0.08 mm
Finger > 0.08 mm | Similar |

8

Finger min 0.08 mm
Powder Free
ResidueASTM D3578-
2019$\leq 2$ mg/glove$\leq 2$ mg/gloveSame
Watertight
(1000 ml)ASTM D3578-
2019Passes AQL-2.5Passes AQL-1.5Similar
Label and LabelingFDA Label
requirementsMeets FDA's
requirementsMeets FDA's
requirementsSame

| CHARACTER

STICSSTANDARDSDEVICE PERFORMANCEComparison
PREDICATE
K121926PROPOSED
DEVICE
K221157
Bio-compatibilityPrimary Skin
Irritation-ISO
10993-10:2010
(E)Gloves are non-
irritatingUnder the condition
of study not an
irritantSimilar
Bio-compatibilityDermal
Sensitization-
ISO 10993-
10:2010( E)Gloves do not
display any
potential for
sensitizationUnder the conditions
of the study not a
sensitizerSimilar
Bio-compatibilityIn vitro
cytotoxicity
ISO10993-5
:2009(E)No Data AvailableUnder the
conditions of the
study, cytotoxic----
Bio-compatibilityAcute
systemic
toxicityUnder the
conditions of the
study no
systemic
toxicity
Bio-compatibilityMaterial
Mediated
Pyrogenicity
ISO 10993-
11:2017(E) /
USP 41No Data AvailableUnder the
conditions of the
study non
pyrogenic----

Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as tested per

ASTM D6978

Carmustine (BCNU) (3.3 mg/ml)15.4 Minutes23.8 MinutesDifferent
Carboplatin (10 mg/ml)Not Tested>240 MinutesDifferent
Cisplatin (1 mg/ml)>240 Minutes>240 MinutesSame
Cyclophosphamide (Cytoxan)
(20 mg/ml)>240 Minutes>240 MinutesSame
Dacarbazine (10.0 mg/ml)>240 Minutes>240 MinutesSame
Doxorubicin HCl (2 mg/ml)>240 Minutes>240 MinutesSame

9

Etoposide (20 mg/ml)>240 Minutes>240 MinutesSame
Fluorouracil (50 mg/ml)>240 Minutes>240 MinutesSame
Ifosfamide (50 mg/ml)Not Tested>240 MinutesDifferent
Methotrexate (25 mg/ml)>240 Minutes>240 MinutesSame
Mitomycin C (0.5 mg/ml)>240 Minutes>240 MinutesSame
Mitoxantrone (2 mg/ml)Not Tested>240 MinutesDifferent
Paclitaxel (6 mg/ml)>240 Minutes>240 MinutesSame
Thiotepa (10 mg/ml)1.6 Minutes24.1 MinutesDifferent
Vincristine Sulfate (1 mg/ml)>240 Minutes>240 MinutesSame

10

G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

Test MethodPurposeAcceptance CriteriaResult
ASTM D3578-2019 Standard
Specification for Rubber Examination
GlovesTo determine the
length of the glovesMin 230 mm for all sizesSmall 304 mm
Medium 304 mm
Large 305 mm
X-Large 305 mm
ASTM D3578-2019 Standard
Specification for Rubber Examination
GlovesTo determine the width
of the glovesSmall 80+/-10mm
Medium 95+/-10 mm
Large 111+/-10 mm
X-Large 115+/-10 mmSmall 84 mm
Medium 94 mm
Large 105 mm
X-Large 114 mm
Test MethodPurposeAcceptance
CriteriaResult
ASTM D3578-2019 Standard
Specification for Rubber
Examination GlovesTo determine the thickness of
the glovesPalm 0.08 mm min
Finger 0.08 mm min
for all sizesSize
Small
Medium
Large
X-LargePalm Finger
0.31mm 0.38mm
0.31mm 0.38mm
0.31mm 0.38mm
0.31mm 0.38mm
To Determine the physical
properties-Tensile strengthBefore Ageing
Tensile Strength
18Mpa Min for all
sizes
After Ageing
Tensile Strength
14Mpa Min for all
sizesSize
Small
Medium
Large
X-LargeBefore After
ageing ageing
33.16 Mpa 30.78 Mpa
32.93 Mpa 30.73 Mpa
32.43 Mpa 30.23 Mpa
32.36 Mpa 30.16 Mpa
ASTM D3578-2019
Standard Specification for
Rubber Examination GlovesTo Determine the physical
properties-Ultimate ElongationBefore Ageing
Ultimate Elongation
650% Min for all
sizes
After Ageing
Ultimate Elongation
500% Min for all
sizesSize
Small
Medium
Large
X-LargeBefore After
ageing ageing
1320% 1066%
1288% 1105%
1376% 1225%
1200% 1041%
To Determine the physical
properties-stress at 500%
ElongationBefore Ageing
5.5 Mpa Max for all
sizesSize
Small
Medium
Large
X-LargeBefore
ageing NA
5.1 Mpa
5.2 Mpa
5.2 Mpa
5.2 Mpa
ASTM D5151-2019 Standard
Test Method for Detection of
Holes in Medical GlovesTo determine the holes in the
glovesAQL 2.5Gloves Passes AQL 1.5
ASTM D6124-06
(Reapproved 2017) Standard
Test Method for Residual
Powder on Medical GlovesTo determine the residual
powder in the gloves2 Mg/Glove MaxSize
Small
Medium
Large
X-LargeResidual Powder
Content
0.21 mg/glove
0.22 mg/glove
0.22 mg/glove
0.22 mg/glove
ASTM D 5712-95 ( Re
approved 2010) Standard Test
Method for the Analysis of
Protein in Natural RubberTo determine the extractable
protein in the gloves.200 µg/ dm² Max for
all sizesSize
Small
Medium
Large
X-LargeExtractable
Protein content
43.12 µg/ dm²
41.16 µg/ dm²
42.06 µg/ dm²
46.24 µg/ dm²
Test MethodPurposeAcceptance CriteriaResult
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
RabbitsUnder the
condition of
study not an
irritantUnder 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 determine the skin
sensitization potential of the
material both in terms of
induction and elicitation in
Guinea Pig.Under the
conditions of the
study not a
sensitizerUnder 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 mouse fibroblasts cells
using elution method.Under the
conditions of
study non
cytotoxicUnder the conditions
of the study cytotoxic.
Acute systemic toxicityTo determine the acute
systemic toxicity potential
of the test item in Swiss
albino miceUnder the conditions
of the study, no
systemic toxicity
Material Mediated
Pyrogenicity ISO 10993-
11:2017(E) / USP 41To determine the pyrogenic
potential of the test item
extract following
intravenous injection in
New Zealand white RabbitsUnder the
conditions of the
study non
pyrogenicUnder the conditions of
the study non pyrogenic

11

H. BIO-COMPATIBILITY DATA

I. CLINICAL TESTING SUMMARY

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

J. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs is as safe, as effective, and performs as well as or better than the legally marketed predicate device Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² or Less of Water-Soluble Protein) K121926.