K Number
K212802
Device Name
powder free nitrile examination glove - white, non-sterile
Date Cleared
2021-12-02

(91 days)

Product Code
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
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

Not Found

No
The device description and performance studies focus on the physical properties and barrier function of a medical glove, with no mention of AI or ML.

No.
The device (patient examination glove) is intended to prevent contamination between patient and examiner, which is a preventive measure, not a therapeutic action to treat or alleviate a disease or condition.

No

Explanation: This device is a patient examination glove, which is used to prevent contamination between the patient and examiner. Its intended use and description do not involve diagnosing any medical condition or disease.

No

The device is a physical examination glove made of nitrile rubber, which is a hardware component. The description focuses on the physical properties and testing of the glove, not software functionality.

No, 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 purposes that is worn on the examiner's hand or finger 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 diagnostic purposes.
  • Device Description: The description focuses on the physical properties and material of the glove, not on any components or processes related to analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions
    • Reagents, calibrators, or controls

The device is a medical device, specifically a Class I or Class II medical device (depending on the specific regulations and intended use claims), but it falls under the category of personal protective equipment used in a medical setting, not 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 - White, 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

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

Description of the test set:

  • Physical Properties: Evaluated for tensile strength and ultimate elongation before and after aging.
  • Dimension: Measured length, width, and thickness for varying glove sizes (X-Small, Small, Medium, Large, X-Large).
  • Watertight: Tested for detection of holes that leak water.
  • Residual Powder: Determined the amount of residual powder and non-powder solids found on gloves.

Sample size:

  • Physical Properties: Not explicitly stated, but results for tensile strength and elongation are provided.
  • Dimension: Not explicitly stated, but measurements are provided for each size.
  • Watertight: Sample size of 315 pieces.
  • Residual Powder: Sample size of 5 pcs.

Data source: Non-clinical tests performed on the subject device.

Annotation protocol: Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Non-clinical testing for physical properties, dimension, watertight integrity, and residual powder.
Sample Size:

  • Physical Properties: Not specified.
  • Dimension: Not specified.
  • Watertight: 315 pcs.
  • Residual Powder: 5 pcs.
    AUC: Not Found
    MRMC: Not Found
    Standalone Performance:
  • Physical Properties (Before Aging): Tensile Strength: 31.4Mpa; Ultimate Elongation: 577%.
  • Physical Properties (After Aging): Tensile Strength: 34.1Mpa; Ultimate Elongation: 541%.
  • Dimension (X-Small): Length: 250 mm; Width: 78.0 mm; Thickness (Finger): 0.10 mm; Thickness (Palm): 0.07 mm.
  • Dimension (Small): Length: 250 mm; Width: 88.0 mm; Thickness (Finger): 0.10 mm; Thickness (Palm): 0.07 mm.
  • Dimension (Medium): Length: 249 mm; Width: 98.0 mm; Thickness (Finger): 0.10 mm; Thickness (Palm): 0.07 mm.
  • Dimension (Large): Length: 249 mm; Width: 108 mm; Thickness (Finger): 0.10 mm; Thickness (Palm): 0.07 mm.
  • Dimension (X-Large): Length: 250 mm; Width: 118 mm; Thickness (Finger): 0.10 mm; Thickness (Palm): 0.07 mm.
  • Watertight: 1 piece was found with leaks, falling within acceptance criteria for AQL 1.5.
  • Residual Powder: 0.21 mg/glove.

Key Results:
All non-clinical tests showed that the device passed the acceptance criteria for physical properties, dimension, watertightness, and residual powder content. The device is concluded to be as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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

  • Tensile Strength (Before Aging): 31.4Mpa (Min 14.0 MPa accepted)
  • Ultimate Elongation (Before Aging): 577% (Min 500% accepted)
  • Tensile Strength (After Aging): 34.1Mpa (Min 14.0 MPa accepted)
  • Ultimate Elongation (After Aging): 541% (Min 400% accepted)
  • Watertight: 1 piece leakage out of 315 samples (AQL 1.5, Acceptance No. 10)
  • Residual Powder: 0.21 mg/glove (Less than 2 mg per glove accepted)

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.

K171615

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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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: K212802

Trade/Device Name: powder free nitrile examination glove - white, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Christopher K. Dugard -S

For Clarence W. Murray, III, Ph.D. Acting 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) K212802

Device Name POWDER FREE NITRILE EXAMINATION GLOVE - WHITE, 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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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(Amended on 24th Nov 2021)

2.0 Identification of the subject device:

Trade Name: Powder Free Nitrile Examination Glove - White, 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:

K171615

Xingyu Nitrile Powder Free Patient Examination Gloves, White Color Company: Shandong Xingyu Gloves Co., Ltd

Description of The Device: 4.0

Powder Free Nitrile Examination Glove - White, 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 Indication for use:

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.

4

Comparison of the Technological Characteristics of the Device: 6.0

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

5

Table 1

CHARACTERISTICSSTANDARDSDEVICE PERFORMANCECOMPARISON ANALYSIS
PREDICATECURRENT
WHITEWHITE
510(k) Number-K171615
Manufacturer(s)-Shandong Xingyu Gloves Co., LtdHong Seng Gloves Sdn BhdSame
MaterialASTM D6319NitrileNitrileSame
Color-WhiteWhiteSame
Physical PropertiesASTM D6319
Before Aging
Tensile Strength:
Ultimate Elongation:18-25Mpa
560-600%31.4Mpa
577%Different but
within the ASTM
standard
After Aging
Tensile Strength:
Ultimate Elongation:17-21Mpa
460-560%34.1Mpa
541%Different but
within the ASTM
standard
Thickness:
  • Finger
  • Palm | ASTM D6319 | 0.08mm
    0.08mm | 0.10mm
    0.07mm | Different but
    within the ASTM
    standard |
    | Powder Free | ASTM D6124 | Below 2mg of residual powder | 0.21 mg/glove | Different but
    within the ASTM
    standard |
    | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
    | | | PREDICATE | CURRENT | |
    | | | WHITE | WHITE | |
    | Biocompatibility | Primary Skin Irritation
  • ISO 10993-10:2010
    (E) & Consumer
    Product Safety
    Commission Title 16.
    Chapter II, Part 1500 | Under the conditions of this
    study, the test article was a
    non-irritant or non-sensitizer.

SKIN IRRITATION DERMAL and
SENSITIZATION STUDIES Meets
ISO 10993-10: Third Edition
2010-08-01 | 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) & Consumer
Product Safety
Commission, Title 16,
Chapter II, Part
1500.3 (c) (4) | Under the conditions of this
study, the test article was a
non-irritant or non-sensitizer.

SKIN IRRITATION DERMAL and
SENSITIZATION STUDIES
Meets ISO 10993-10: Third
Edition 2010-08-01 | The test material did not
produce a skin sensitization
effect in the guinea pigs. | Similar |
| | Cytotoxicity - MEM
Elution, ISO 10993-5:
2009 (E) | Not Tested | The test material
demonstrated a cytotoxic
effect under the condition of
this study. Additional test i.e.
Acute Systemic Toxicity was
tested | Different |
| | | DEVICE PERFORMANCE | | |
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON
ANALYSIS |
| | | WHITE | WHITE | |
| Biocompatibility | Acute Systemic
Toxicity, ISO 10993-
11:2017 (E) | Not Tested | The test item did not induce
any systemic toxicity in Swiss
albino mice. | Different |
| Watertight (1000ml) | ASTM D5151:2019 | Meets
21 CFR 800.20ASTM D6319-10
(Reapproved 2015) Tested in accordance with ASTM
D5151 (Reapproved 2015) with
acceptable results | Gloves passed AQL 1.5 | Similar |
| Intended use | - | Powder Free Nitrile Patient
Examination Gloves, White
Color 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 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 |
| Size | Medical Glove
Guidance Manual -
Labeling | Small
Medium
Large
X Large | Extra Small
Small
Medium
Large
Extra Large | Similar |
| Single use | Medical Glove
Guidance Manual -
Labeling | Single Patient Use | Single Use | Same |

6

7

8

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.

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| Test
Method | Standard | Purpose of Testing | | Acceptance Criteria
Before
aging | After
aging | Results
Before
aging | After
aging | Status |
|------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|----------------------------------------|-----------------|----------------------------|----------------|--------|
| Physical
Properties | ASTM D412
(Standard Test
Method for
Vulcanized Rubber
and Thermoplastic
Elastomers-Tension) | To evaluate the
tensile (tension)
properties of glove. | Tensile
strength | Min 14.0
MPa | Min 14.0
MPa | 31.4Mpa | 34.1Mpa | Pass |
| | | | Ultimate
elongation | Min
500% | Min
400% | 577% | 541% | Pass |

10

| Test
Method | Standard | Purpose of
Testing | Glove
Size | Acceptance Criteria | Results | Status | |
|----------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------|---------------|-------------------------------------------------------|---------------------------------|---------|------|
| Dimension | ASTM D3767
Standard
Practice for
Rubber—
Measurement
of Dimensions | To measure the
length, width and
thickness of
glove | X-Small | Length
Min 240 mm | Length
250 mm | Pass | |
| | | | | Width
$70 \pm 10$ mm | Width
78.0 mm | Pass | |
| | | | | Thickness
Finger - min 0.05mm
Palm - min 0.05mm | Thickness
0.10 mm
0.07 mm | Pass | |
| | | | Small | Length
Min 240 mm | Length
250 mm | Pass | |
| | | | | Width
$80 \pm 10$ mm | Width
88.0 mm | Pass | |
| | | | | Thickness
Finger - min 0.05mm
Palm - min 0.05mm | Thickness
0.10 mm
0.07 mm | Pass | |
| | | | Medium | Length
Min 240 mm | Length
249 mm | Pass | |
| | | | | Width
$95 \pm 10$ mm | Width
98.0 mm | Pass | |
| | | | | Thickness
Finger - min 0.05mm
Palm - min 0.05mm | Thickness
0.10 mm
0.07 mm | Pass | |
| | | | Large | Length
Min 240 mm | Length
249 mm | Pass | |
| | | | | Width
$110 \pm 10$ mm | Width
108 mm | Pass | |
| | | | Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass |
| | | | | Palm - min 0.05mm | | 0.07 mm | |
| | | | Length | Min 240 mm | Length | 250 mm | Pass |
| | | X-Large | Width | $120 \pm 10$ mm | Width | 118 mm | Pass |
| | | | Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass |
| | | | | Palm - min 0.05mm | | 0.07 mm | |

11

12

| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Watertight | ASTM 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: 315 pcs
Inspection level: G1
AQL: 1.5, Acceptance No.
10 | The batch size for this
sampling is 150,001 to
500,000. Hence,
according to the single
sampling plan G1, 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. During the test, 1
piece was found with
leaks. Hence it falls
within the acceptance
criteria. | Pass |

| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------|--------|
| Residual
Powder | ASTM D6124
(Standard Test
Method for Residual
Powder on Medical
Gloves) | To determine the
amount of
residual powder
and non-powder
solids found on
gloves. | Less than 2 mg per glove | Sample size : 5 pcs
Requirement :