(62 days)
N.A.
Not Found
No
The device description and intended use clearly describe a physical examination glove made of latex, with no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is a glove intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is a latex examination glove intended to prevent contamination between patient and examiner, acting as a barrier, not to diagnose a medical condition.
No
The device description explicitly states it is made of natural rubber latex films and describes its physical properties and manufacturing process, indicating it is a physical hardware device (a glove).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used externally.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This glove does not perform any such examination of specimens.
- Device Description: The description focuses on the physical properties of the glove as a barrier and its manufacturing standards. It doesn't mention any components or processes related to analyzing biological samples.
The device is a medical device, specifically a medical glove, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
"a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner."
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
a. HOW THE DEVICE FUNCTIONS: Natural rubber latex films form a barrier to body fluids and bloodborne pathogens
b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
c. PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS AND PHYSICAL PROPERTIES: Natural rubber latex is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the reguirements of ASTM D3578-06 and ASTM D5151 requirements.
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
examiner / medical purposes
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)
DISCUSSION OF NON-CLINICAL TESTS
SPECIFICATION: Powdered
PERFORMANCE STANDARDS: ASTM D3578-06
WATER TIGHTNESS: ASTM D5151-92
PROTEIN: ASTM D5712-05
DISCUSSION OF CLINICAL TESTS
SPECIFICATION: SAFETY
RABBIT IRRITATION: Passes
GUINEA PIG SENSITIZATION: Passes
CONCLUSION DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE
The data summaries indicate that the product meets or exceeds acceptable scores nonclinical tests, and satisfies the requirements for a safe and effective in powdered medical glove.
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.
N.A.
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
Attachment #8 - 510(k) Summary
SUMMARY OF 510(k) Submission
NOV 1 9 2007
A. INFORMATION
| 1. SUBMITTER'S NAME: |
|---|
| ---------------------- |
Shandong Yuyuan Latex Gloves Co., Ltd
1296, Industrial Park, Linqing City, Shandong 252600, China
+86-635-297-1167
Jessie Sun Jing_______________________________________________________________________________________________________________________________________________________________
July 2007
TELEPHONE NUMBER:
ADDRESS:
CONTACT PERSON:
DATE SUMMARY PREPARED:
-
- NAME OF DEVICE TRADE OR PROPRIETARY NAME: Yuyuan Powdered Latex Examination Glove
Examination Glove
- NAME OF DEVICE TRADE OR PROPRIETARY NAME: Yuyuan Powdered Latex Examination Glove
COMMON OR USUAL NAME:
CLASSIFICATION NAME:
Examination Glove
-
- PREDICATE DEVICE IDENTIFICATION N.A. N.A. N.A. B. B. B. B. B. B. B. B. B. B. B. NAME, NUMBER
-
- DESCRIPTION OF DEVICE
- a. HOW THE DEVICE FUNCTIONS: Natural rubber latex films form a barrier to body fluids and bloodborne pathogens
- b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
- c. PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS AND PHYSICAL PROPERTIES: Natural rubber latex is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the reguirements of ASTM D3578-06 and ASTM D5151 requirements.
1
-
- STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR CONDITIONS THAT THE DEVICE WILL ADDRESS This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Examination gloves with protein content labeling are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor. Powdered gloves have increased donnability over wet hands.
- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE 6. N.A.
- B. IF SE DECISION BASED ON PERFORMANCE DATA
-
- DISCUSSIOM OF NON-CLINICAL TESTS
-
| SPECIFICATION | Powdered |
|---|---|
| PERFORMANCE STANDARDS | ASTM D3578-06 |
| WATER TIGHTNESS | |
| PROTEIN | ASTM D5151-92 |
| ASTM D5712-05 |
-
- DISCUSSION OF CLINICAL TESTS
SPECIFICATION SAFETY RABBIT IRRITATION Passes GUINEA PIG SENSITIZATION Passes
- DISCUSSION OF CLINICAL TESTS
-
- CONCLUSION DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE
The data summaries indicate that the product meets or exceeds acceptable scores nonclinical tests, and satisfies the requirements for a safe and effective in powdered medical glove.
- CONCLUSION DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE
Pursuant to 21 C.F.R.807.87 (i), I, Jessie Sun Jing, Sales and Marketing Executive of Shandong Yuyuan Latex Gloves Co., Ltd, certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Sales and Marketing for Shandong Yuyuan Latex Gloves Co., Ltd, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.
Jessie Sun Jing Sales and Marketing Manager
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2007
Ms. Jessie Sun Shandong Yuyuan Latex Gloves Company, Limited No. 1296 Industrial Park Linqing City, Shandong CHINA 252600
Re: K072639
Trade/Device Name: Yuyuan Latex Examination Glove, Powdered Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 9, 2007 Received: November 14, 2007
Dear Ms. Sun:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Sun
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nil R.P. Ogl
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the indications for Use Statement.
INDICATION S FOR USE
Shandong Yuyuan Latex Gloves Company Ltd Applicant: 510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________ New Application "Yuyuan Latex Examination Glove, F Device Name:
Indications For Use:
The Yuyuan, Latex Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." (21CFR 880.6250)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Shule M. Murphy MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072639
Prescription Use __ OR Over-The-Counter _
Per 21 CFR 801.109
(Optional Format 1-2-96)
For a new submission, do NOT fill in the 510(k) number blank