GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)

K964321 · Shijiazhuang Hongray Plastic Products Co., Ltd. · LYZ · Jan 9, 1997 · General Hospital

Device Facts

• Record ID: K964321
• Device Name: GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)
• Applicant: Shijiazhuang Hongray Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Vinyl patient examination glove; ambidextrous; prepowdered. Worn by healthcare personnel to provide a protective barrier against contamination. Device acts as a physical barrier between the wearer and patient fluids/waste. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data. Biocompatibility testing performed including primary dermal irritation in rabbits and Guinea Pig sensitization (Buehler). Bench testing conducted per ASTM D5250 and FDA water leak test (pinhole rate <4%).

Technological Characteristics

Vinyl material; prepowdered; ambidextrous; 10-inch length. Thickness: 0.08mm (finger), 0.09mm (cuff), 0.15mm (palm). Tensile strength min 10.0 MPa; elongation min 350%. Meets ASTM D5250 and JIS-S-2045 standards.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient's body, fluids, waste, or environment.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}

K964321

H-RAY

JAN - 9 1997

# ShiJiaZhuang HongRay Plastic Products Co., Ltd.

HEAD OFFICE NO. 135 XIN HUA WEST ROAD, SHIJIAZHUANG CITY,
&amp; FACTORY HEBEI PROVINCE, CHINA
P.O. BOX, 050081
TEL. [phone] 334221
BRANCH OFFICE, RM3, 5TH FL., NO. 76 FUSHING SOUTH ROAD,
SECTION I, TAIPEI, TAIWAN
P.O. BOX, 53-186, TAIPEI
TEL. [phone] 7110338 7217339
FAX. [phone] TELEX. 22602 KENAN

OUR REF. 510(K) SUMMARY - K964321

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}

H-RAY

Shijiazhuang HongRay Plastic Products Co., Ltd.

HEAD OFFICE NO. 135 XIN HUA WEST ROAD, SHIJIAZHUANG CITY, K. FACTORY ' HEBEI PROVINCE, CHINA

P.O. BOX, 050081

TEL. [phone] 334221

BRANCH OFFICE, RM3, 5TH FL., NO. 76 FUSHING SOUTH ROAD, SECTION I, TAIPEI, TAIWAN

P.O. BOX, 53-186, TAIPEI

TEL. [phone] 7110338 7217339

FAX. [phone] TEL.EX, 22602 KENAN

YOUR REF.

510(K) SUMMARY Page 2 of 2

## 9.0 Quality Characteristics

SPECIFICATION OF VINYL GLOVES
(ANBIDEXTROUS)
POWDER 10"

| SIZE
SPEC | SMALL | MEDIUM | LARGE | X-LARGE | TEST CODE |
| --- | --- | --- | --- | --- | --- |
| CIRCUMFERENCE
OF PALM (M/M)
(INCH) | 178
6-3/4 | 210
7-3/4 | 218
8-1/2 | 230
9 | JIS-S-2045.5.9 |
| TOTAL LENGTH
(±5M/M) | 240 | 245 | 245 | 245 | JIS-S-2045.5.9 |
| LNGTH OF
FINGERS (M/M)
THUMBS | 55 | 57 | 61 | 63 | JIS-2045.5.9 |
| INDEX FINGER | 66 | 70 | 75 | 78 | |
| MIDDLE FINGER | 74 | 81 | 88 | 92 | |
| RING FINGER | 69 | 74 | 79 | 82 | |
| LITTLE FINGER | 54 | 55 | 60 | 62 | |
| CIRCUMFERENCE
FINGERS
THUMB | 63 | 71 | 78 | 83 | JIS-S-2045.5.9 |
| INDEX FINGER | 56 | 64 | 70 | 74 | |
| MIDDLE FINGER | 59 | 66 | 72 | 76 | |
| RING FINGER | 56 | 63 | 69 | 73 | |
| LITTLE FINGER | 50 | 57 | 62 | 66 | |
| 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 | ±0.2g |
| 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 |

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