(186 days)
Not Found
No
The device is a simple medical examination glove, and the summary focuses on physical and biocompatibility testing, with no mention of AI or ML.
No.
The device is described as an examination glove intended to prevent contamination, not to treat or alleviate a medical condition.
No
The device description clearly states it is a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This indicates its function is protective, not diagnostic. The performance studies focus on physical properties and biocompatibility, not on detecting, diagnosing, or treating diseases or conditions.
No
The device is a physical product (gloves) and the summary describes physical and biocompatibility testing, 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 is "to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description clearly states it's a "patient examination glove."
- 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
- Performance Studies: The performance studies focus on physical properties (dimensions, strength, thickness, water tightness) and biocompatibility, which are relevant for a barrier device, not an IVD.
IVD devices are used to examine specimens taken from the human body to provide information for diagnostic purposes. This device is a physical barrier worn on the hand.
N/A
Intended Use / Indications for Use
Nitrile Medical Examination Gloves is 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
Nitrile Examination Gloves Powder Free-Black 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 black in color and are powder free and non-sterile.
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 testing, which includes: Standards for Dimensions, Physical Properties, Thickness, Powder Residue, Water Tightness, Material, Color, Texture, and Size. Biocompatibility data was also collected, including Primary Skin Irritation, Dermal Sensitization, In vitro cytotoxicity, and Acute Systemic Toxicity Test.
Results shown in tables indicate that the subject device meets the acceptance criteria for all tested characteristics and standards (ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06 (Reapproved 2017), ISO 10993-10, ISO 10993-5:2009, ISO 10993-11:2017).
The conclusion is that "The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, Nitrile Examination Gloves Powder Free-Black is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192333."
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.
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 contains 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.
October 25, 2022 JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Drive, Ste 114 Aurora, Illinois 60504
Re: K221169
Trade/Device Name: JR MEDIC Nitrile Examination Gloves Powder Free- Black Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 20, 2022 Received: October 20, 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. In addition, there must not be any claim or documentation (now or in the future) indicating "extra protection" or "customer request".
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 and Part 809; 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 medical devices and radiation-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 THT4B2: Personal Protective Equipment, Reprocessing & Disinfection Devices Team DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality CDRH | Food and Drug Administration
Enclosure
2
Indications for Use
510(k) Number (if known) K221169
Device Name
JR MEDIC Nitrile Examination Gloves Powder Free- Black
Indications for Use (Describe)
Nitrile Medical Examination Gloves is 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION K221169
| 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 |
| ganeshjrmt@gmail.com | |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | +6012 224 6677 |
| Contact Email | ganeshjrmt@gmail.com |
| Date Submitted | 12 April 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | Nitrile Examination Gloves Powder Free-Black |
|---|---|
| Product proprietary or trade name | JR Medic |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD |
|---|---|
| 510(K) Number | K192333 |
| Regulatory Class | 1 |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Nitrile Examination Gloves Powder Free-Black 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 black in color and are powder free and non-sterile.
E. INTENDED USE OF THE DEVICE:
Nitrile Examination Gloves Powder Free is a disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
4
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATEDEVICE
| Characteristics | Standards | Device Performance | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | K221169 | ---- | |
| Name of device | JR MEDIC Blue Nitrile Examination Gloves Powder-free | Nitrile Examination Gloves Powder Free-Black | ---- | |
| Dimensions | ASTM D6319-2019 | Length Min 230 m Width Min 95+/-10 mm(for medium size) | Length Min 230 mm Width Min 95+/-10 mm(for medium size) | 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 |
| Biocompatibility | Primary Skin Irritation- ISO 10993-10:2010(E) | |||
| Dermal Sensitization- ISO 10993-10:2010( E) | ||||
| In vitro cytotoxicity ISO10993-5 :2009(E) | ||||
| Acute Systemic Toxicity Test ISO 10993-11:2017(E) | ||||
| Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41 | Under the condition of study not an irritant | |||
| Under the conditions of the study not a sensitizer | ||||
| Under the conditions of the study, cytotoxic | ||||
| Under the conditions of study the device extracts do not pose a systemic toxicity concern | ||||
| Under the conditions of the study non pyrogenic | Under the condition of study not an irritant | |||
| Under the conditions of the study not a sensitizer | ||||
| Under the conditions of the study cytotoxic | ||||
| Under the conditions of study the device extracts do not pose a systemic toxicity concern | ||||
| No data available | Same | |||
| Characteristics | Standards | Device Performance | Remarks | |
| Predicate | Current | |||
| Water Tight (1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | JR MEDIC Blue Nitrile | |||
| Examination Gloves | ||||
| Powder-free is | ||||
| disposable devices | ||||
| intended for medical | ||||
| purpose that are won on | ||||
| the examiner's hand to | ||||
| prevent contamination | ||||
| between patient and | ||||
| examiner. | Nitrile Examination | |||
| Gloves Powder free is | ||||
| a disposable devices | ||||
| intended for medical | ||||
| purpose that are worn | ||||
| on the examiner's | ||||
| hand to prevent | ||||
| contamination | ||||
| between patient and | ||||
| examiner. | Similar | |||
| Material | ASTM | |||
| D6319-2019 | Nitrile | Nitrile | Same | |
| Color | - | Blue | Black | 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 |
| Manufacturer(s) | - | JR Engineering &
Medical
Technologies
(M) SDN.BHD.
Malaysia | JR Engineering &
Medical
Technologies
(M) SDN.BHD.
Malaysia | ------ |
5
K221169
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.
NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA Result Test Method Purpose Acceptance Criteria ASTM D6319-2019 Standard To determine the Min 230 mm for all sizes X-Small:- 483 mm Specification for Nitrile length of the gloves Small:-484 mm Examination Gloves for Medium:- 485 mm Medical Application Large:-486 mm X-Large:- 486 mm ASTM D6319-2019 Standard determine 70+/-10 mm To the X-small:- X-small-74 mm Specification for Nitrile width of the gloves Small:-80+/-10 mm Small:-84 mm Examination Gloves for Medium:- 95+/-10mm Medium:- 94 mm Medical Application Large:-110+/−10 mm Large:-104 mm X-Large:- 120+/-10 mm X-Large:- 115 mm
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| Test Method | Purpose | Acceptance
Criteria | Result | | |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 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
0.19mm
0.19mm
0.19mm
0.19mm
0.19mm | Finger
0.21mm
0.21mm
0.21mm
0.21mm
0.21mm |
| ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application | To Determine the
physical properties-
Tensile strength | Before Ageing
Tensile Strength
14Mpa Min for all
sizes
After Ageing
Tensile Strength
14Mpa Min for all
sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
ageing
18.44Mpa
18.49Mpa
18.56Mpa
18.62Mpa
18.64Mpa | After
ageing
17.49Mpa
17.53Mpa
17.65Mpa
17.71Mpa
17.76Mpa |
| ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application | To Determine the
physical properties-
Ultimate Elongation | Before Ageing
Ultimate Elongation
500% Min for all
sizes
After Ageing
Ultimate
Elongation 400%
Min for all sizes | Size
X-Small
Small
Medium
Large
X-Large | Before
ageing
683%
687%
692%
695%
698% | After
ageing
656%
660%
663%
666%
669% |
| Test Method | Purpose | Acceptance
Criteria | Result |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5151-2019 Standard
Test Method for Detection of
Holes in Medical Gloves | To determine the
holes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 |
| 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
X-small
Small
Medium
Large
X-Large
Residual Powder
Content
0.16 mg/glove
0.16 mg/glove
0.16 mg/glove
0.16 mg/glove
0.16 mg/glove |
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BIO-COMPATIBILITY 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 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 | |||
| 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 | |||
| mouse fibroblasts cells using | |||
| elution method. | Under the | ||
| conditions of study | |||
| non cytotoxic | Under the conditions of | ||
| the study cytotoxic. | |||
| 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 |
G. Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
H. CONCLUSION
The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, Nitrile Examination Gloves Powder Free-Black is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192333.