K Number
K031020
Device Name
FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
Date Cleared
2003-05-21

(51 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.
More Information

Not Found

Not Found

No
The document describes standard latex examination gloves and makes no mention of AI or ML technology.

No
The device, "Latex Examination Gloves," is intended for preventing contamination between patient and examiner, not for treating or rehabilitating a medical condition.

No
The device, "Latex Examination Gloves, Powdered, Non-Sterile", is intended to prevent contamination between patient and examiner, not to diagnose a medical condition.

No

The device is a physical product (latex gloves) and does not involve any software component.

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 "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
  • Device Description: The description focuses on the material (Natural Rubber Latex) and performance standards related to physical properties (ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test), which are typical for examination gloves.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. Examination gloves do not perform such tests.

N/A

Intended Use / Indications for Use

The Latex Examination Glove, Powdered, Non Sterite ia a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of Natural Rubber Latex 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)

LYY

Device Description

The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.

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

Not Found

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

The Latex Examination Gloves, Powdered, Non Sterile are summanized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS: Dimensions, Physical Properties, Freedom from Pinholes, Powder Amount, Biocompatability
STANDARDS: D 3578 - 01a2, D 3578 - 01a2, D 3578 - 01a2, FDA 21 CFR 800.20, D 3578 - 01a2, D 6124 - 01, Primary Skin Irritation in Rabbits, Dermal Sensitization
DEVICE PERFORMANCE: Meets, Meets, Meets,

§ 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

PT. Mandiri Inti Buana

MAY 21 2003

Jalan Listrik No, 6 Medan-20112 INDONESIA

  • 62-81-45860
  • 62-81-46860

510 (K) SUMMAR

1.0 Submitter :

NamePT. Mandiri Inti Buana
AddressJl. Listrik No.6
Medan - Indonesia, 200112.
Phone No.+61 4566506
Fax No.+61 4566806

Date of Summary Prepared :

Contact Person :

2.0

Name:Mr. Ng Poy Sir
Phone No.:+61 4566506
Fax No.:+61 4566808

Name of the device : 3.0

| Trade Name | 1). Flexiskin, and
2). Multiple or Customers' Trade Name |
|---------------------|-------------------------------------------------------------|
| Device Name | : Latex Examination Gloves, Powdered, Non-Sterile |
| Common Name | : Examination Gloves |
| Classification Name | : Patient Examination Gloves (Class 1) |

ldentification of The Legally Marketed Device : 4.0

Class I patient examination gloves, 80LYY, powdered, that meets all the requirements of ASTM standard D 3578 - 01a82 and FDA 1000 ml Water Leak Test.

Description of The Device : 5.0

The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.

Intended Use of the Device : 6.0

The Latex Examination Glove, Powdered, Non Sterite ia a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

1

PT. Mandiri Inti Buana

Jalan Liatrik No. 6 Medan-20112 INDONESIA

KO3/020/51

+62-61-4666506 Tel + 62-81-4566806 883

Summary of The Technological Characteristics of The Device : 7.0

The Latex Examination Gloves, Powdered, Non Sterile are summanized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|------------------------------------|----------------------------------------|
| Dimensions | D 3578 - 01a2 | Meets |
| Physical Properties | D 3578 - 01a2 | Meets |
| Freedom from Pinholes | D 3578 - 01a2
FDA 21 CFR 800.20 | Meets |
| Powder Amount | D 3578 - 01a2
D 6124 - 01 |