K Number

Device Name

ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-09-13

(55 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

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

Device Description

Class I latex patient examination gloves 80LYY, 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 device is a standard medical glove and the summary does not mention any AI or ML components or functionalities.

Therapeutic

No
This device, a medical glove, is intended to prevent contamination between healthcare personnel and patients, and its function is not to treat or cure a disease or condition.

Diagnostic

No
The device is a medical glove, designed to prevent contamination, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

The device is a physical medical glove made of latex, not a software application. The description focuses on material properties and physical performance tests.

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 the patient by being worn on the hand. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
Device Description: It's described as a Class I latex patient examination glove. This is a physical barrier device.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The performance studies focus on physical properties, water tightness, biocompatibility, and residual protein levels – all related to the glove's function as a barrier and its safety for the user and patient.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. 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.

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

Product codes

80LYY

Device Description

Class I latex patient examination gloves 80LYY, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves) After Real Time Ageing On Gloves Produced in 1994.
Water Tight Test After Real Time Ageing: Using the FDA specified 1,000 ml water leak test, 80 pieces of the gloves produced in 1994 over a period of three years of storage were tested.
Biocompatibility: Primary Dermal Irritation Test, Skin Sensitization Study.
Residual Protein Level: ASTM D 5712-95.
Key results:

meets/exceeds ASTM- D3578-95 Standard Specifications For Latex Examination Glove
meets FDA pinhole requirements
meets SHIELD's shelf life labeling claim of four years
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 H

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES

Contact person : Ong Lay Mau

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

Device Information:

Trade Name - ROYAL SHIELD 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 80LYY, 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 80LYY, 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		Size Fitted
Width	X-Small	70 mm +/- 10 mm	5.5	70 +/- 10 mm
	Small	80 mm +/- 10mm	6.0	76 +/- 10mm
	Medium	95 mm +/- 10mm	6.5	83 +/- 10mm
	Large	111mm +/- 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

2. Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves) After Real Time Ageing On Gloves Produced in 1994.

	TENSILE STRENGTH		ULTIMATE ELONGATION
DATE
TESTED	AGED
SHIELD	AGED
ASTM	UNAGED
SHIELD	UNAGED
ASTM	AGED
SHIELD	AGED
ASTM	UNAGED
SHIELD	UNAGED
ASTM
10.3.97	21.8	14.0	25.1	14.0	975	500	922	700
10.3.98	27.3	14.0	27.3	14.0	877	500	790	700
11.3.99	22.0	14.0	26.2	14.0	928	500	854	700

Batch # 9410243147 & 9411153155

3. Water Tight Test After Real Time Ageing

Using the FDA specified 1,000 ml water leak test, 80 pieces of the gloves produced in 1994 over a period of three years of storage were tested and our results are as given below:

| BATCH # | DATE
TESTED | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|--------------|----------------|-------------|-------------|------------------|
| 9410243147/ | Mar 10, 1997 | 125 | Yes | 2 |
| 9411153155 | Mar 10, 1998 | 125 | Yes | 1 |
| Size L/R 6.0 | Mar 11, 1999 | 125 | Yes | 2 |

The above figures are within the FDA/draft ASTM 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	-	Profer Donor ham on less of Total Water extreastable probes gram Indications For Use :

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

... ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODE)

OR Over-The-Counter .. Prescription Use ... ... Per 21 CFR 801.109 (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number