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K Number
K212804
Device Name
Powder free nitrile examination glove- blue, non-sterile
Manufacturer
Hong Seng Gloves Sdn Bhd
Date Cleared
2021-12-01

(90 days)

Product Code
LZA
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A 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.
Device Description
Powder Free Nitrile Examination Glove - Blue, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
More Information

K192333

Not Found

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

No
Gloves are used to prevent contamination between patient and examiner, not to provide therapy.

No

A diagnostic device is one used to identify the nature or cause of a disease or condition. This device, a patient examination glove, is intended for preventing contamination, not for diagnosis.

No

The device is a physical examination glove made of nitrile rubber, which is a hardware component, not software.

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

Here's why:

  • Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
  • Device Description: The description focuses on the physical properties and manufacturing of a glove. It does not mention any components or functions related to analyzing biological samples.
  • Performance Studies: The performance studies described are related to the physical integrity, strength, and biocompatibility of the glove, which are relevant for a barrier device, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other characteristics typically associated with IVD devices.

Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

A 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.

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

LZA

Device Description

Powder Free Nitrile Examination Glove - Blue, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner / medical purposes

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 test data was summarized.
Physical Properties test: Tensile Strength (28.6Mpa before aging, 33.1Mpa after aging) and Ultimate Elongation (579% before aging, 535% after aging) passed.
Watertight test: 500 pcs were tested, 1 piece was found with leaks, which falls within the acceptance criteria, hence passed.
Powder Free test: 0.26mg/glove, passed (acceptance criteria

§ 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.

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December 1, 2021

Hong Seng Gloves Sdn Bhd Michael Van Der Woude U S Agent Emergo Global Representative LLC, 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746

Re: K212804

Trade/Device Name: Powder free nitrile examination glove- blue, non-sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 12, 2021 Received: September 2, 2021

Dear Michael Van Der Woude:

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

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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,

For Clarence W. Murray III, 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212804

Device Name POWDER FREE NITRILE EXAMINATION GLOVE - BLUE, NON STERILE

Indications for Use (Describe)

A 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.

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

K212804

1.0 Submitter:

Name:Ho Chia Yao
Address:Hong Seng Gloves Sdn Bhd
Lot 97, Jalan 10, Kawasan Perusahaan Bakar Arang, 08000,
Sungai Petani, Kedah, Malaysia
Phone No.:+604-4211555
Fax No.:+604-4211555

Date of Summary Prepared: 20th July 2021 (REVISED DATE: 30th NOVEMBER 2021)

2.0 Identification of the subject device:

Trade Name: Powder Free Nitrile Examination Glove - Blue, Non-Sterile
Common Name: Patient Examination Gloves
Classification Name:Patient Examination Gloves Device
Classification: 1
Regulation Number: 21 CFR 880.6250
Product Code: LZA.

3.0 Predicate Device:

K192333

Blue Nitrile Examination Gloves Powder Free Company: JR Engineering & Medical Technologies (M) SDN. BHD.

4.0 Description of The Device:

Powder Free Nitrile Examination Glove - Blue, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

5.0 Intended Use/Indication for use:

A patient examination glove is a disposable device made of nitrile rubberintended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

6.0 Comparison of the Technological Characteristics of the Device:

The Powder Free Nitrile Examination Glove - Blue, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.

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Table 1

| CHARACTERISTICS
STANDARDS | | DEVICE PERFORMANCE | | COMPARISON
ANALYSIS |
|----------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | | PREDICATE
BLUE | CURRENT
BLUE | |
| 510(k) Number | - | K192333 | K212804 | |
| Manufacturer(s) | - | JR Engineering & Medical
Technologies (M) SDN. BHD. | Hong Seng Gloves Sdn Bhd | Same |
| Intended
use/Indications for Use | - | JR MEDIC Blue Nitrile Examination
Gloves Powder Free is disposable
devices intended for medical purpose
that are worn on the examiner's
hand to prevent contamination
between patient and examiner. | A patient examination glove is a
disposable device made of nitrile
rubber intended for medical
purposes that is worn on the
examiner's hand or finger to prevent
contamination between patient and
examiner. | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger texture | Finger Texture | Same |
| Physical Properties
Before Aging
Tensile Strength:
Ultimate Elongation: | ASTM D6319 | 25.6Mpa
868% | 28.6Mpa
579% | Different but
within the ASTM
standard |
| After Aging
Tensile Strength:
Ultimate Elongation: | ASTM D6319 | 22.0Mpa
828% | 33.1Mpa
535% | Different but
within the ASTM
standard |
| Thickness:

  • Finger
  • Palm | ASTM D6319 | 0.22mm
    0.20mm | 0.10mm
    0.07mm | Different but
    within the ASTM
    standard |
    | Powder Free | ASTM D6124 | 0.21 mg/glove | 0.26 mg/glove | Different but
    within the ASTM
    standard |
    | Watertight (1000ml) | ASTM
    D5151:2019 | Gloves passes AQL 1.5 | Gloves passed AQL 1.5 | Same |
    | Size | Medical Glove
    Guidance Manual
    – Labeling | 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 |
    | | Primary Skin
    Irritation
    – ISO 10993-
    10:2010
    (E) | Under the condition of study not an
    irritant | The test material did not cause an
    irritant response. The Primary
    Irritant Response Category is
    deemed `Negligible' | Similar |
    | | Dermal
    Sensitization- ISO
    10993-10: 2010
    (E) | Under the conditions of the study not
    a sensitizer | The test material did not produce a
    skin sensitization effect in the guinea
    pigs. | Similar |
    | Biocompatibility | Cytotoxicity -
    MEM Elution, ISO
    10993-5:
    2009 (E) | Under the conditions of the study,
    cytotoxic. Additional testing was
    performed to determine if this was a
    systemic toxicity concern. | The test material demonstrated a
    cytotoxic effect under the condition
    of this study. Additional test i.e.
    Acute Systemic Toxicity was
    tested. | Similar |
    | | Acute Systemic
    Toxicity, ISO
    10993-
    11:2017 (E) | Under the conditions of study, the
    device extracts do not pose a
    systemic toxicity concern | The test item did not induce any
    systemic toxicity in Swiss albino
    mice. | Similar |

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There are no significant differences between the two products and they are the same or similar in terms of intended use, materials design, physical properties, thickness and biocompatibility test.

7.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

| Test

MethodStandardPurpose of TestingAcceptance CriteriaResultsStatus
Before
agingAfter
agingBefore
agingAfter aging
Physical
PropertiesASTM D412
(Standard Test
Method for Vulcanized
Rubber and
Thermoplastic
Elastomers-Tension)To evaluate the
tensile (tension)
properties of glove.Tensile
strengthMin
14.0
MPaMin 14.0
MPa28.6Mpa33.1MpaPass
Ultimate
elongationMin
500%Min
400%579%535%Pass
WatertightASTM D5151
(Standard Test
Method for
Detection of Holes in
Medical Gloves)To detect holes that
leak water and
thereby compromise
the usefulness of the
glove.Sample size: 500 pcs Inspection
level: G1
AQL: 1.5, Acceptance No. 10Less than 2 mg per gloveThe batch size for this sampling
is 150,001 to 500,000. Hence,
according to the single
sampling plan GI, the sample
to be drawn is under code M
equivalent to 315 pieces with
accept 10 and reject 11 to be
accepted under AQL
1.5. 500 pcs were tested, 1
piece was found with leaks.
Hence it falls within the
acceptance criteria.Pass
Sample size : 5 pcsRequirement :