GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)

• K Number: K994426
• Device Name: GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)
• Manufacturer: PT. WRP BUANA MULTICORPORA
• Date Cleared: 2000-05-23 ( 145 days)
• Product Code: LYY
• Regulation Number: 880.6250

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment. The Examination Glove is a medical glove which is disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between examiner and patient.

Device Description

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard examination glove and provides performance data related to physical properties and watertightness, with no mention of AI or ML.

Therapeutic

No.
The device description and intended use clearly state that these are examination gloves intended to prevent contamination, not to provide therapy for a disease or condition.

Diagnostic

No.
The device is described as an examination glove intended to prevent contamination, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a Class I Latex Patient Examination Glove, which is a physical hardware product. The performance studies and key metrics also relate to the physical properties of the 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 clearly states the gloves are for preventing contamination between healthcare personnel and patients/environment. This is a barrier function, not a diagnostic one.
• Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D3578-99), which are relevant to its barrier function and safety for use on the hand.
• Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
• Performance Studies: The performance studies focus on physical properties like watertightness, length, width, thickness, tensile strength, and protein content – all related to the glove's function as a physical barrier.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This glove is used on the body as a protective barrier.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

The Examination Glove is a medical glove which is disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between examiner and patient.

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

LYY

Device Description

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

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

healthcare personnel 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)

Performance data of gloves to ASTM D 3578-99 and FDA 1000 ml Watertight Test.
The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578 - 99.
Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95 below 100 µg/g.

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

Watertight (1000 ml): G-1 ; AQL 1.5
Length (mm):
XS: Not Found
S: 230 Min.
M: 230 Min.
L: 230 Min.
XL: Not Found
Palm Width (mm):
XS: Not Found
S: 80 +/- 10
M: 95 +/- 10
L: 111 +/- 10
XL: Not Found
Thickness (mm):
Palm: 0.08 Min.
Finger: 0.08 Min.
Physical Properties. Before Ageing: S-2 ; AQL 4.0

• Tensile Strength (MPa): 21 MPa Min.
• Ultimate Elongation (%): 700% Min.
  After Ageing:
• Tensile Strength (MPa): 16 MPa Min.
• Ultimate Elongation (%): 500% Min.
  Powder Content: Below 110 mg/glove
  Moisture Content: 0.8 Max.
  Protein Content: Below 100 µg/g

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

0

Image /page/0/Picture/0 description: The image shows the logo for PT WRP Buana Multico. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed in a rounded shape. To the right of the logo is the text "PT WRP Buana Multico", with the last part of the text being partially obscured.

Jalan Jermal, No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA

TEL [phone] [phone] FAX [phone] URL www.wrpworld.com

510(K) SUMMARY K9946

• 1. Trade Name : Glovetex Examination Gloves, Powdered Non-Sterile ( Protein Cont
     (Protein Content Labeling)
     (100 MICROGRAMS or LESS)
• 2. Common Name : Examination Gloves
     MAY 2 3 2000
• 3. Classification Name : Patient Examination Glove

4. Substantial Equivalence :

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

• ട്. Description of Device :
  Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

• 6. Intended use of Device :
     The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

1

7. Summary of Performance Data :

Performance data of gloves to ASTM D 3578-99 and FDA 1000 ml Watertight Test.

	TEST	ASTM D 3578 - 99	In-house Specification for
			Glovetex Examination Gloves,
Powdered, Non-Sterile
			( Protein Content Labeling )
1.	Watertight (1000 ml)	G-1 ; AQL 2.5	G-1 ; AQL 1.5
2.	Length ( mm)
	Size
XS
	S	220 Min.	230 Min.
	M	230 Min.	230 Min.
	L	230 Min.	230 Min.
	XL
3.	Palm Width (mm)
	Size
XS
	S	$80 \pm 10$	$80 \pm 10$
	M	$95 \pm 10$	$95 \pm 10$
	L	$111 \pm 10$	$111 \pm 10$
	XL
4.	Thickness (mm)
	Palm	0.08 Min.	0.08 Min.
	Finger	0.08 Min.	0.08 Min.
5.	Physical Properties.
Before Ageing :	S-2 ; AQL 4.0	S-2 ; AQL 4.0
	- Tensile Strength (MPa)	14 MPa Min.	21 MPa Min.
	- Ultimate Elongation (%)	700% Min.	700% Min.
	After Ageing :
	- Tensile Strength (MPa)	14 MPa Min.	16 MPa Min.
	- Ultimate Elongation (%)	500% Min.	500% Min.
6.	Powder Content.	-	Below 110 mg/glove
7.	Moisture Content.	-	0.8 Max.
8.	Protein Content.	-	Below 100 µg/g

2

Substantial Equivalence Based on Assessment of Non-Clinical Performance Data : 8.

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578 - 99.

Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95 below 100 µg/g.

9. Conclusion.

The gloves that is to be marketed meets all the requirements of ASTM D 3578-99 and has a low detectable level of protein ( of about