K Number

Device Name

ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-09-13

(55 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Device Description

Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

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 summary describes a standard medical glove and contains no mention of AI or ML technology.

Therapeutic

No
The device is a medical glove intended for preventing contamination, not for treating a disease or condition.

Diagnostic

Explanation: The device is a medical glove intended for preventing contamination, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device is a physical medical glove, not a software application. The description clearly states it is a "Class I latex patient examination glove."

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to prevent contamination between healthcare personnel and patients by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
Device Description: The device is described as a Class I latex patient examination glove meeting a specific ASTM standard. This is consistent with a medical device used for protection, not for in vitro diagnosis.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.

IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality. This glove does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Product codes

LYY

Device Description

Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care and similar personnel

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

The data presented indicate that the Royal Shield Powdered latex examination glove

1. meets/exceeds ASTM- D3578-99 Standard Specifications For Latex Examination Glove,
1. meets FDA pinhole requirements,
1. meets the protein labeling claim level at

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

APPENDIX F

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD PINK COLORED POWDERED LATEX EXAMINATION GLOVES WITH AND WITHOUT STRAWBERRY SCENTING & A PROTEIN LABELLING CLAIM

Contact person : Ong Lav Mau

This summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990.

Device Information:

Trade Name - ROYAL SHIELD COLORED POWDERED LATEX EXAMINATION GLOVES Common Name - Exam gloves

Classification Name - Patient examination glove (per 21 CFR 880.6250)

Classification Information - Class I latex patient examination glove 80LY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

Device Description:

Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Technological Characteristics of Device:

1. Dimension

DIMENSION		Ambidextrous
Width		X-Small 70 mm +/- 10 mm
Small 80 mm +/- 10mm
Medium 95 mm +/- 10mm
Large 111mm +/- 10mm	5.5 70 +/- 10 mm
6.0 76 +/- 10mm
6.5 83 +/- 10mm
7.0 89 +/- 10mm
7.5 95 +/- 10mm
8.0 102 +/- 10mm
8.5 108 +/- 10 mm
9.0 114 +/- 10mm
Length		230 mm
Thickness -	Finger
Palm	0.08 mm min
0.08 mm min

	TENSILE STRENGTH				ULTIMATE ELONGATION
DATE	AGED		UNAGED		AGED		UNAGED
TESTED	SHIELD	ASTM	SHIELD	ASTM	SHIELD	ASTM	SHIELD	ASTM
20 May 99	26.7	14.0	26.4	14.0	980	500	880	700
20 May 99	24.7	14.0	27.1	14.0	900	500	900	700
20 May 99	27.4	14.0	30.3	14.0	930	500	900	700

2. Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves)

3. Water Tight Test Data

| BATCH # | DATE
TESTED | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|--------------|----------------|-------------|-------------|------------------|
| 9009-9037 XS | 19 May 99 | 200 | Yes | 5 |
| 9019-9023 S | 19 May 99 | 315 | Yes | 3 |
| 9030-9039 M | 19 May 99 | 200 | Yes | 3 |

The above figures are within the ASTM D-3578-99 requirements for latex exam gloves of 2.5% AQL.

4. Biocompatibility

The test results below show that the gloves meet FDA biocompatibility requirements:

BIOCOMPATIBILITY TESTS	RESULTS
Primary Dermal Irritation Test	Not a primary irritant
Skin Sensitization Study	Not a sensitiser

5. Residual Protein Level

TESTS	FDA ALLOWABLE LEVEL	CLAIMED LEVEL
ASTM D 5712-95	-