(131 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a disposable medical glove, with no mention of AI or ML.
No.
The device's intended use is to prevent contamination between healthcare personnel/examiner and the patient, fluids, or environment, which is a barrier function, not a therapeutic one.
No
The device description clearly states it is a "Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)." Its intended use is to prevent contamination between healthcare personnel/examiner and the patient, fluids, waste, or environment. This function is for protection and barrier, not for diagnosing medical conditions.
No
The device description clearly states "Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)", indicating a physical hardware device. The performance studies and key metrics also relate to physical properties of the glove, not software performance.
No, 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 the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic function.
- Device Description: The description is for a physical barrier (a glove).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information about a patient's health status or disease.
- Performance Studies and Metrics: The performance studies and metrics focus on the physical properties and integrity of the glove (tensile strength, elongation, pinhole rate, etc.), which are relevant to its barrier function, not diagnostic accuracy.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)
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
health care and similar personnel / Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains Chinese characters followed by the English text "EVERGREEN MEDICAL PRODUCTS CO., LTD." The Chinese characters are above the English text. The text is in a sans-serif font and is black on a white background. The image appears to be a company logo or heading.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, lingxing County, Shijiazhuang City, Hebei 050306, China Tel: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
APR 1 2 2000
Date: Feb. 22, 2000 Total pages: 3
1.0 APPLICANT:
Evergreen Medical Products (Jingxing) Co., Ltd. No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306 China Tel: +(86 311) 236 1035, 236 0652 Fax: +(86 311) 236 0670 E-mail: chenjul@ms13.hinet.net
2.0 Contact Person:
Doreen Feng Tel: +(86 311) 236 1035, 236 0652 Fax: +(86 311) 236 0670
3.0 DEVICE CLASS: JY
PRODUCT CODE: Vinyl (Pre-Powdered) - 80 LYZ
- 4.0SPECIFICATION: Glove, Patient Examination, Vinyl (Pre-powdered) Meet all the current specifications listed under ASTM Specification D 5250-99
5.0 DEVICE DESCRIPTION:
Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)
6.0 INDICATION FOR USE (INTENDED USE):
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.
7.0INNER SURFACE: Pre-powdered
8.0 BIOCOMPATIBILITY TESTING:
- Primary Dermal Irritation in Rabbits -
- -Guinea Pig Sensitization (Buehler)
Issued by Consumer Products Testing Co.
1
Image /page/1/Picture/0 description: The image shows the name of a company in both Chinese and English. The Chinese characters are at the top, and the English name, "EVERGREEN MEDICAL PRODUCTS CO., LTD." is below. The English name is in a bold, sans-serif font and has a textured fill. There is a line underneath the English name.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 el: + (86 311) 236 1018, 236 1035
9.0 QUALITY CHARACTERISTICS
510 (K) Summary: Page 2
SPECIFICATION OF VINYL GLOVES (Ambidextrous)
| Size
| Spec. | Small | Medium | Large | Ex-Large | Test code |
|---|---|---|---|---|---|
| Circumference | |||||
| of Palm (mm) | |||||
| (Inch) | 178 | ||||
| 6-3/4 | 210 | ||||
| 7-3/4 | 218 | ||||
| 8-1/2 | 230 | ||||
| 9 | JIS-S-2045.509 | ||||
| Total Length | |||||
| (+/- 5 mm) | 240 | 245 | 245 | 245 | JIS-S-2045.5.9 |
| Length of | |||||
| Fingers (mm) | |||||
| Thumbs | |||||
| Index Finger | |||||
| Middle Finger | |||||
| Ring Finger | |||||
| Little Finger | 55 | ||||
| 66 | |||||
| 74 | |||||
| 69 | |||||
| 54 | 57 | ||||
| 70 | |||||
| 81 | |||||
| 74 | |||||
| 50 | 61 | ||||
| 75 | |||||
| 83 | |||||
| 79 | |||||
| 60 | 63 | ||||
| 78 | |||||
| 92 | |||||
| 82 | |||||
| 62 | JIS-S-2045.5.9 | ||||
| Circumference | |||||
| Fingers (mm) | |||||
| 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. | ||||
| 10.0 | Min. | ||||
| 10.0 | Min. | ||||
| 10.0 | JIS-S-2045.5.2 | ||||
| Elongation (Min.) | 350% | 350% | 350% | 350% | JIS-S-2045.5.2 |
| Weight (g/pc) | 7.0 | 8.0 | 9.0 | 9.5 | +/- 0.2g |
| Thickness | Finger Tip | ||||
| 0.08 mm +/- 0.02 mm | |||||
| Cuff | |||||
| 0.09 mm +/- 0.02 mm | |||||
| Palm | |||||
| 0.15 mm +/- 0.02 mm | |||||
| Quality | |||||
| Assurance | Under 2.5% Pinhole Rate | FDA Glove 1000ml | |||
| Water Leak Test |
2
Image /page/2/Picture/0 description: The image shows the name of a company in both Chinese and English. The Chinese characters at the top read "Chang Rong Medical Products Co., Ltd." Below this, the English translation "EVERGREEN MEDICAL PRODUCTS CO., LTD." is displayed in a bold, outlined font. The English text is set against a textured background, adding visual interest to the company's name.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, "ingxing County, Shijiazhuang City, Hebei 050306, China : +(86 311) 236 1018, 236 1035 Fax: +(86 311) 236 0670
510 (K) Summary: Page 3
10.0 CONCLUSION:
The vinyl Patient Examination gloves (Pre-powdered) manufactured by Evergreen Medical products (Jingxing) Co., Ltd. meet ASTM D5250-99 Standard and meet pinhole requirements and labeling claims.
3
Image /page/3/Picture/0 description: The image shows the text "EVERGREEN MEDICAL PRODUCTS CO., LTD." in a bold, sans-serif font. Above this text is the same company name in Chinese characters. The English text is underlined with a thin black line.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, lingxing County, Shijiazhuang City, Hebei 050306, China Tel: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
Total pages: 6
GENERAL QUALITY CONTROL SCHEME
1.0 PRODUCT
Vinyl Patient Examination Gloves Pre-Powdered, Non-Sterile
2.0 INTENDED USE
A medical glove is to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluid, waste, or environment".
3.0 DONNING POWDER
U. S. P. Absorbable Dusting Powder, Neutral pH
- U. S. FDA approved under ANDA (Abbreviated new Drug Application 809535)
U. S. FDA Medical Device Establishment manufacturing Registration Number for manufacturing site.
Name of supplier of USP powder: Shieh-Tai Chemical & Starch Co., Ltd. Brand name of USP powder: Modified Starch Extra 226.
4.0 COMPONENTS
| Polyvinyl Chloride | 45.90% |
|---|---|
| Di-2-Ethylhexyl Phthalate | 45.90% |
| 2,2,4-Trimethyl-1, 3-Pentanediol | 4.50% |
| Calcium, Zinc Sterates | 2.30% |
| Epoxidized Soyabean Oil | 0.50% |
| Absorbable Powder for Lubrication | 0.5 mm |
| Embedded particles > 1 mm, more than 2 per glove | |
| Thin spots | |
| Discoloration, blooming | |
| Torn, broken or open bead | |
| Pleats, lumps in non-critical area | Visual |
| Visual | |
| Visual |
- End of document -
9
Image /page/9/Picture/2 description: The image shows a black and white logo of the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes. The words "DEPARTMENT OF HEALTH & H.S." are arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2000
Ms. Doreen Feng Evergreen Medical Products (Jingxing) Co., Ltd. No. 1, Evergreen Road The North of Beishimen Village Xiaozuo Town, Jingxing County Shijiazhuang City, Hebei 050306 CHINA
Re : K994099 Vinyl Patient Examination Gloves- Pre-Trade Name: powdered Requlatory Class: I Product Code: LYZ February 22, 2000 Dated: Received: April 3, 2000
Dear Ms. Feng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your
10
Page 2 - Ms. Feng
premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo v A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
11
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Tel: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
INDICATION FOR USE STATEMENT
| Applicant: | Evergreen Medical Products (Jingxing) Co., Ltd. |
|---|---|
| 510(K) Number: | K994099 |
| Device Name: | Vinyl Patient Examination Gloves - Pre-powdered |
Indication for use:
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Concurrence of CDRH Office of Device Evaluation (ODE)
Claire S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 5100k) Number .
Prescription Use _ Per 21 CFR 801.109
Over-The-Counter OR