GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)

• K Number: K964321
• Device Name: GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)
• Manufacturer: SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
• Date Cleared: 1997-01-09 ( 72 days)
• Product Code: LYZ 80L
• Regulation Number: 880.6250

Intended Use

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Description

Glove, Patient Examination, Vinyl (Powdered)

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard examination glove and contains no mention of AI or ML technologies.

Therapeutic

No.
The device description and intended use indicate it is a patient examination glove meant for contamination prevention, not for treating a disease or condition.

Diagnostic

No
The device, a patient examination glove, is intended to prevent contamination between healthcare personnel and patients. Its described function does not involve diagnosing conditions or identifying diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Glove, Patient Examination, Vinyl (Powdered)", which is a physical hardware device.

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's body, fluids, waste, or environment. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
• Device Description: The device is a "Glove, Patient Examination, Vinyl (Powdered)". This is a physical barrier device.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances
  • Providing information for diagnosis, monitoring, or screening

Therefore, this device falls under the category of a medical device, specifically a barrier device, rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Product codes

80LYZ

Device Description

Glove, Patient Examination, Vinyl (Powdered)

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

healthcare 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)

The device meets all of the requirements of ASTM Standard D5250, including compliance with pinhole requirements and labeling claims. Biocompatibility testing was performed, including Primary Dermal Irritation in Rabbits and Guinea Pig Sensitization (Buehler) by Consumer Products Testing Co., USA. Quality Assurance indicates an "UNDER 4% PINHOLE RATE" as tested by the "FDA GLOVE 1000 ML WATER LEAK TEST".

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

UNDER 4% PINHOLE RATE

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

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

K964321

Image /page/0/Figure/1 description: This image contains the letterhead for ShiJiaZhuang HongRay Plastic Products Co., Ltd. The head office is located at NO. 135 XIN HUA WEST ROAD in SHIJIAZHUANG CITY, Hebei Province, China, with the postal code 050081. The branch office is located at RM3, 5TH FL., NO. 76 FUSHING SOUTH ROAD, SECTION 1 in Taipei, Taiwan, with the postal code 53-186.

1.0 APPLICANT: MR. LIN CHIN YU SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. NO. 135 XIN-HUA WEST RD. SHIJIAZHUANG, CHINA TEL. [phone] FAX. [phone]

• 2.0 CONTACT PERSON MR. LIN CHIN YU SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS NO. 135 XIN-HUA WEST RD. SHIJIAZHUANG, CHINA TEL. [phone] FAX. [phone]
  AGENT : MR. DON MORRIS 14 LEEWARD ISLAND CLEARWATER, FL. 34630 USA TEL. [phone] FAX. [phone]

• 3.0 Device Class: 1 Product Code: 80LYZ

• 4.0 Specification: Glove, Patient Examination, Vinyl (Powdered) meets all of the requirements of ASTM Standard D5250

• 5.0 Device Description: Glove, Patient Examination, Vinyl (Powdered)

• 6.0 Intended Use: A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

• 7.0 Inner Surface: Prepowdered

• 8.0 Biocompatibility Testing: Primary Dermal Irritation in Rabbits and Guinea Pig Sensitization (Buehler) by Consumer Products Testing Co., USA.

1

Image /page/1/Figure/0 description: This image shows the letterhead for ShiJiaZhuang HongRay Plastic Products Co., Ltd. The letterhead includes the company's head office address, factory address, phone number, branch office address, and fax number. The head office is located at NO, 135 XINHUA WEST ROAD, SHIJIAZHUANG CITY, and the branch office is located at RM3, 5TH FL., NO. 76 FUSHING SOUTH ROAD, SECTION 1. TAIPEI, TAIWAN.

510(K) SUMMARY

Page 2 of 2

9.0 Quality Characteristics

| SIZE

SPEC	SMAI.I.	MEDIUM	1.ARGE	X-LARGE	TEST CODE
CIRCUMFERENCE
OF PALH (H/W)
(INCH)	178
6-3/4	210
7-3/4	218
8-1/2	230
9	JIS-S-2045.5.9
TOTAL LEENGTH
(± 5M/H)	240	245	245	245	JIS-S-2045.5.9
LNGTH OF
FINGERS (H/H)
THUMBS
INDEX FINGER
MIDDLE FINGER
RING FINGER
LITTLE FINGER	55
66
74
69
54	57
70
81
74
55	61
75
88
79
60	63
78
92
82
62	JIS-2045.5.9
CIRCUMFERENCE
FINGERS
THUMB
INDEX FINGER
MIDDLE FINGER
RING FINGER
LITTLE FINGER	63
56
59
56
50	71
64
66
63
57	78
70
72
69
62	83
74
76
73
66	JIS-S-2045.5.9
TENSILE STRENGTH
(Mpa)	Min.
10.0	Min.
10.00	Min.
10.00	Min.
10.00	JIS-2045.5.2
ELONGATION
(Min.)	350%	350%	350%	350%	JIS-2045.5.2
WEIGHT (g/pc)	7.0	8.0	9.0	9.5	±0.2%
THICKNESS	Finger Tip 0.08mm ± 0.02mm
Cuff 0.09mm ± 0.02mm
Palm 0.15mm ± 0.02mm
QUALITY
ASSURANCE	UNDER 4% PINHOLE RATE				FDA GLOVE 1000
ML WATER LEAK
TEST

SPECIFICATION OF VINYL GLOVES (AMBIDEXTROUS) POUDER

• 10.0 Conclusion: Shinjiazhuang Hongray Plastic Products Co., Ltd. Vinyl Patient Examination Gloves meet ASTM Standards - meets pinhole requirements and labeling claims.