K Number

Device Name

NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)

Manufacturer

PT. EKA WIRA ASIA

Date Cleared

1998-04-02

(36 days)

Product Code

LZA FEB

Regulation Number

880.6250

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.

Device Description

Private Label - Nitrile Examination Gloves Pre-Powdered, Blue and White Color

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

Not Found

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.

Therapeutic

No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a medical condition.

Diagnostic

Explanation: The device is a patient examination glove, intended to prevent contamination. Its function is not to diagnose any condition or disease.

SaMD (Software as a Medical Device)

The device is a physical examination glove, not a software application.

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 a "patient examination glove...worn on examiner's hand or finger to prevent contamination between patient and examiners." This describes a physical barrier device used for protection and hygiene during patient examination.
IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose. The device's function is purely a physical barrier.

Therefore, based on the provided information, the device is a medical device, but it falls under the category of a protective barrier device, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.

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

LZA

Device Description

Trade Name : Private Label - Nitrile Examination Gloves Pre-Powdered, Blue and White Color
Classification Name : Patient Examination Gloves

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

worn on examiner's hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical purpose

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)

(5) Technological characteristic of the gloves.
- g. Dimensions
  | SIZES | SMALL | MEDIUM | LARGE |
  |---|---|---|---|
  | Length (min) mm
  Palm width mm
  Thickness | 240
  $85 \pm 10$ | 240
  $95 \pm 10$ | 240
  $111 \pm 10$ |
  | 1. Cuff (min)

Palm (min)
Fingertip (min) | 0.1
0.1
0.1 | 0.1
0.1
0.1 | 0.1
0.1
0.1 |

h. Physical Properties
| Tensile Strength | 14 Mpa | 14 Mpa |
|---|---|---|
| Ultimate Elongation (min) | 700 % | 500 % |

Before Aging

Performance Requirement i. Inspection Related defeats Characteristic Level

Watertightness	Holes	S - 4
Dimension	Width, length
Thickness	S - 2	4
Physical Properties	Before & After
Aging	S-2	4

Weight of residual powder in medium size gloves: 150 ± 50 mg j.

k. Bio-Compatibility (attached)	Annexure XI
l. Test Results as per ASTM D 3578 - 95 (attached)	Annexure V

(6) Performance data is the same as mentioned immediately above.
(7) Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
(8) Non-clinical data Gloves meet or exceed the ASTM Standard. Meet FDA pin holes requirement. Meet labeling claim.

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.

Not Found

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

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

Mar-13-98 12:02P G S I
APR - 2 1998
P.04

	K980729
--	---------

	PT. EKA WIRA ASIA
	Jl. Haji Zainal Arifin 128 B-C
	Medan 20112 - Indonesia

	Tel. 62-61-328888 (Hunting)
	62-61-520688 (Direct)
	62-61-730008
	Fax. 62-61-520588
	62-61-730008

	Page Numbers 1 of 2
	SUMMARY OF 510(K) SUBMISSION # K980729
(1) Name of applicant	: Mr. Hansen Laurence
Address	: PT. EKA WIRA ASIA
	Jl. Haji Zainal Arifin 128 B-C
	Medan 20112 - Indonesia
Phone No.	62-61-328888; 62-61-730008
Fax No.	62-61-520588; 62-61-730007

The contact persons within the firm as well as in U.S.A. are given below:

Contact person in firm	: Mr. Hansen Laurence
Fax No.	62-61-520588; 62-61-730007
Contact person in U.S.A.	: Emmy Tjoeng
Fax No.	562-693-8866

(2) Device details
Trade Name	: Private Label - Nitrile Examination Gloves
	Pre-Powdered, Blue and White Color
Classification Name	: Patient Examination Gloves
Product Code	: Nitrile 80 LZA
(3) Equivalent device legally marketed	: Class I Nitrile Examination Gloves 80 LZA Pre-Powdered
	meeting ASTM D 3578 - 95
(4) Intended use	: A patient examination glove is a disposable device intended
	for medical purpose that is worn on examiner's hand or finger
	to prevent contamination between patient and examiners.

2121

FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG

Image /page/1/Picture/2 description: The image shows a black and white logo. The logo is circular and contains a figure standing with their legs apart and arms raised. Above the figure are several lines radiating outwards, resembling sun rays. There are also two horizontal lines on either side of the figure.

EKA WIRA ASIA

Jl. Haji Zainal Arifin 128 B-Medan 20112 - Indonesia

"|"click. 62-61 - 328888 (11. 62-61 - 520688 (1)ire 62-61 - 730008 ドはメ 62-61 - 520588 62-61 - 730008

Page Numbers 2 of 2

After Aging at 100° for 22 hrs

AQL

SUMMARY OF 510(K) SUBMISSION # K980729

(5) Technological characteristic of the gloves.
- g. Dimensions

SIZES	SMALL	MEDIUM	LARGE
Length (min) mm
Palm width mm
Thickness	240
$85 \pm 10$	240
$95 \pm 10$	240
$111 \pm 10$
1. Cuff (min)

Palm (min)
Fingertip (min) | 0.1
0.1
0.1 | 0.1
0.1
0.1 | 0.1
0.1
0.1 |

h. Physical Properties

Tensile Strength	14 Mpa	14 Mpa
Ultimate Elongation (min)	700 %	500 %

Before Aging

Performance Requirement i. Inspection Related defeats Characteristic Level

Watertightness	Holes	S - 4
Dimension	Width, length
Thickness	S - 2	4
Physical Properties	Before & After
Aging	S-2	4

Weight of residual powder in medium size gloves: 150 ± 50 mg j.

k. Bio-Compatibility (attached)	Annexure XI
l. Test Results as per ASTM D 3578 - 95 (attached)	Annexure V

(6) Performance data is the same as mentioned immediately above.
(7) Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
(8) Non-clinical data Gloves meet or exceed the ASTM Standard. Meet FDA pin holes requirement. Meet labeling claim.

FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 1998

PT. Eka Wira Asia ·C/O Ms. Emmy Tjoeng Official Correspondent for PT, Eka Wira Asia Glove Source, Incorporated 12110 East Slauson Avenue #3 Santa Fe Springs, California 90670

Re : K980729 Nitrile Examination Gloves - Powdered Blue Trade Name: and White Requlatory Class: I LZA Product Code: February 23, 1998 Dated: February 25, 1998 Received:

Dear Ms. Tjoeng:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

Page 2 - Ms. Tjoeng

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,
K. Whitaker

Timo v A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/4/Picture/3 description: The image is a black and white logo. The logo features a stylized figure standing with legs apart and arms raised, resembling a person or abstract form. Above the figure, there are radiating lines that suggest sunlight or energy emanating from the figure. The figure and radiating lines are set against a backdrop of two curved shapes that create a sense of enclosure or containment.

EKA WIRA ASIA

Jl. Haii Zainal Arifin 128 B-C Medan 20112 - Indonesia

62-61 - 328888 (Illunling) . ان ا 62-61 - 520688 (1)recel) 62-61 - 73000x 62-61 - 520588 ドは、 62-61 - 730008

ANNEXURE II

INDICATION FOR USE

: Mr.Hansen Laurence Applicant

: K980729 510(k) Number

Device Name

: Nitrile Patient Examination Gloves - Powder . Blue and White Color

Indication for use

A patient examination glove is a disposable device intended for medical purpose that is wom on the examiner's hand or finger to prevent contamination between patient and examiners.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Division of Dontal, Infection Control,

and General Hospital Device

(Division Sign-Oif)

510(k) Number

Over-The Counter-Use X
(Optional Format 1-2-96)

FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG