K Number

Device Name

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

Manufacturer

Megine Industries Sdn Bhd

Date Cleared

2021-06-16

(47 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

The powder-free 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

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitrile - LZA (2 ICFR880.6250). AMADEX - Nitrile Powder Free Examnation Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is single-use device to prevent contamination between patient and examiner.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K172867

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device description and intended use clearly state that the gloves are for preventing contamination, not for treating a disease or condition. They are classified as Class I patient examination gloves.

Diagnostic

The device is described as a glove intended to prevent contamination between patient and examiner, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device described is a physical medical device (examination gloves) and does not involve any software component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed on samples taken from the body.
Device Description: The description confirms it's a "patient examination glove" and references standards related to gloves (ASTM D 6319-10 and FDA 21 CFR 880.6250), not IVD standards.
Lack of Diagnostic Function: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
Performance Studies and Metrics: The performance studies and key metrics focus on the physical properties and barrier function of the glove (length, width, thickness, tensile strength, water tightness, residual powder, biocompatibility), not on diagnostic accuracy or performance.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The powder-free 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

LZA

Device Description

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is single-use device to prevent contamination between patient and examiner.

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)

The non-clinical testing included physical properties (tensile strength, elongation, thickness), dimensions, powder content, watertight integrity, and biocompatibility (primary skin irritation and dermal sensitization).

Key results:

Length: >230 mm (Passes)
Width: 98 +/- 2 mm (Passes)
Thickness: Palm: 0.09 mm (Passes), Finger: 0.12 mm (Passes)
Physical Properties (Tensile Strength): Before Ageing: 24.5 Mpa (Passes)
Holes (Water Tight): AQL 2.5 (Passes)
Residual Powder: 0.60 mg / glove (Passes)
Biocompatibility-Irritation: Under the condition of study not an irritant
Biocompatibility-Sensitization: Under the condition of study not an irritant
Rubber Examination Gloves Specifications (ASTM D 3578-05): Meet the requirements of ASTM 3578 until 5 years (Passes)

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

Not Found

Predicate Device(s)

K172867

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

June 16, 2021

Megine Industries Sdn Bhd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K211310

Trade/Device Name: AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 11, 2021 Received: June 14, 2021

Dear Prithul Bom:

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 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.

Ryan Ortega, PhD 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

Indications for Use

510(k) Number (if known) K211310

Device Name

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange)

Indications for Use (Describe)

The powder-free 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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MEGINE INDUSTRIES SDN BHD

510 (K) SUMMARY ----------

This summary of 510(K) is being submitted in Accordance with requirements of SMDA 1990 and 21 CFR807.92.

Collicit conceller and en artifies

The assigned 510 (K) number is: K211310

I. APPLICANT INFORMATION:

510 (K) Owner's Name	MEGINE INDUSTRIES SDN BHD
Address	B-05-02, The Vertical Business Suites, 8, Jalan Kerinchi,
Bangsar South, 59200 Kuala Lumpur, Malaysia
Phone	+60328566180
Fax	+60328566180
E-mail	benjamin.ng@meginegroup.com.my
Contact Person	Benjamin Ng Soong Jing
Designation	Managing Director
Contact Number	+60328566180
Contact Email	benjamin.ng@rneginegroup.com.my
Date Submission	28th April 2021

AT REAL ME

2. DEVICE IDENTIFICATION:

글

| Name of the Device | AMADEX-Nit1ile Powder Free Examination Gloves Non-
Sterile, (Blue, Black, Orange) |
|--------------------------------------|--------------------------------------------------------------------------------------|
| Product Proprietary or
Trade Name | AMADEX |
| Common or Usual Name | Examination Gloves |
| Classification Name | Patient Examination Glove |
| Device Classification | Class - I |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

3. PREDICATE DEVICE INFORMATION:

| Predicate Device | Nitrite Examination Powder Free Glove, Black, Nitrile
Examination Powder Free Glove, Orange. |
|------------------|-------------------------------------------------------------------------------------------------|
| 510 (K) Number | K172867 |
| Regulatory Class | I |
| Product Code | LZA |

4. DEVICE DESCRIPTION:

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitril e - LZA (2 ICFR880.6250). AMADEX - Nitrile Powder Free Examnation Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is sing le-use device to prevent contamination between patient and examiner.

5. INDICATION OF USE:

The powder-free 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.

Characteristics	Standards	Device Performance		Remark s
		Predicate	Subject	-
5 10 (K) number		K172867	(Kxxxxxx)	-
Name of Device		Nitrile
Examination
Powder Free
Glove, Blac k,
Nitrile
Examination
Powder Free
Glove, Orange.	AMADEX-
Nitrile Powder
Free
Examination
Gloves Non-
Sterile, (Blue,
Black, Orange)	-
Dimension s	ASTM D 6319-10
Length:
Range - Length: Min -240
mm
(All Size s )	Res ult:
Length h:
Min 240mm
By Sizes:	Result:
Length: Min
240mm
By Sizes:	Sam e
	Width:
Range value -
XS : Length : 220mm,
Width: 70 ± 10 mm
S : Length : 220mm,
Width: 80 ± 10mm
M : Length : 230mm,
Width: 95 ± 10 mm
L : Length : 230mm,
Width: 110 ± 10mm
XL : Length : 230mm,
Width: 120 ± 10mm	XS-
Width: 76 ± 3
mm
S -
Width: 84 ± 3
mm
M-
Width: 94 ± 3
mm
L -
Width: 105 ± 3
mm
XL -
Width: 113 ± 3
mm	XS -
Width: 76 ± 3
mm
S-
Width: 84± 3
mm
M-
Width: 94 ± 3
mm
L -
Width: 105 ± 3
mm
XL -
Width: 113 ± 3
mm
Physical
Properties	ASTM D 6319-10
Tensile, Elongation -
Before Aging
Range:
Tensile Strength min: > 14
Mpa
Ultimate Elongation Min:
500%
After Aging
Range:
Tensile Strength min: > 14
Mpa
Ultimate Elongation Min:
400%	Before Aging
Result: 14 Mpa
500%
After Aging
Result: 14 Mpa,
400%	Before Aging
Result: 14 Mpa
500%
After Aging
Result: 14 Mpa
400%	Same
Thickness	ASTM D 6319-10
Range:
Thickness (mm)
Single wall ( All Sizes )
Finger:
Typical Value: (0.10 -
0.12)
Palm:
Typical Value: (0.07 -
0.08)	Result:
Finger: 0.10 ±
0.02
Palm: 0.07 ±
0.02	Result:
Finger: 0.10 ±
0.02
Palm: 0.07 ±
0.02	Same
Powder Free	ASTM S 6319-10	Result:	Result:	Same
	Range:
230 mm (Passes)
ASTM D 6319-10
(Reapproved 2015)
Standard specification
for Nitrile
Examination Gloves
for Medical
Application	To determine the
width of the gloves	$95 \pm 10$ mm	$98 \pm 2$ mm (Passes)
ASTM D 6319-10
(Reapproved 2015)	To determine the
thickness of the gloves	Palm 0.05 mm min
Finger 0.05 mm min	Palm: 0.09 mm
(Passes)

| Standard specification
for Nitrile
Examination Gloves
for Medical
Application | | | Finger: 0.12 mm
(Passes) |
|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| ASTM D 6319-10
(Reapproved 2015)
Standard specification
for Nitrile
Examination Gloves
for Medical
Application | To determine the
physical properties
Tensile strength | Before Ageing:
Tensile strength
14Mpa min | 24.5 Mpa (Passes) |
| ASTM D 5151-06
(Reapproved 2015)
Standard Test method
for Detection of Holes
in Medical Gloves | To determine the holes
in the gloves | AQL 2.5 | AQL 2.5 (Passes) |
| ASTM D 6124-06
(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 | 0.60 mg / glove
(Passes) |
| ASTM D 3578-05
(Reapproved 2015)
Standard Specification
for Rubber
Examination Gloves | To determine the
specifications for
rubber examination
gloves | Dimension, AQL: 4.0
Length: min 230 mm
Force at Break, AQL:
4.0, Tensile and
Modul us | Meet the requirements
of ASTM 3578 until 5
years (Passes) |

b) Bio-Compatibility Data

Test Method	Purpose	Acceptance Criteria	Re sult

MEG/NE INDUSTRIES SON BHD

| ISO 1099 3-10
Biological Evaluation
of Medic al Device
Test for Irritation and
Skin Sensitization.
Test done for
Irritation. | To deter mine the
potential irritation of
the effect likely to
arise from a single
exposure of test
material on the intact
skin of rabbits. | Under the condition of
study not an irritant | Under the condition of
study not an irritant |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------|
| ISO 10993-10
Biological Evaluation
of Medical De vice
Test for Irritation and
Skin Sensitization.
Test done for
sensitization. | To evaluate the
potential of a test
material to cause a
delayed
hypersensitivity
reaction (Type IV)
following exposure of
the skin of guinea pigs. | Under the condition of
study not an irritant | Under the condition of
study not an irritant |

1. Discussion of Clinical tests performed: Not Applicable - Clinical Data is not needed for Gloves or for most devices cleared by the 510 (K) process.
1. Conclusion:

The conclusion drawn from the nonclinical test demonstrate that the subject device in 510 (K) submission Kl 72867. AMADEX Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, and Orange) is as safe, as effective, and performs as well as or better than the legally marketed predicate device.