(125 days)
K#893822, K#941809
K#893822, K#941809
No
The summary describes a standard vinyl examination glove and does not mention any AI or ML capabilities.
No
Explanation: The device is a glove worn by healthcare personnel to prevent contamination and is clearly stated to be a Class I device, not intended for therapeutic purposes.
No
The document describes a patient examination glove, which is a barrier intended to prevent the transmission of contaminants, not to diagnose a disease or condition.
No
The device description clearly identifies the device as a physical glove, a hardware component, and references physical testing standards (ASTM, FDA Water Fill Test, Skin Irritation/Sensitization). There is no mention of software as the primary or sole component.
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, patients, and the environment. This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: It is classified as a "Vinyl Patient Examination Glove" under 21 CFR 880.6250. This classification is for general and plastic surgery devices, not IVDs.
- 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.)
- Providing diagnostic information about a patient's condition
- Using reagents or other diagnostic components
The device is clearly intended for physical protection and barrier purposes in a healthcare setting.
N/A
Intended Use / Indications for Use
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel the patient's body, and fluids, waste or environment.
Product codes
80LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The standards used for Sunmax Enterprise Shanghai Co., glove production are based on ASTM-D-5250-92. Ltd. All testing neets requirements for Physical Dimensions and Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted results showing no primary skin irritant or sensitization reactions.
Key Metrics
Not Found
Predicate Device(s)
K#893822, K#941809
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 A Page 1 of 2
Jun 24 Car
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
The assigned 510(k) number is:_K9607 46
1. Submitter's Identification:
Mr. Ernie Liu Sunmax Enterprise Shanghai Co., Ltd. #2 Zhu Hang New Industry Zone Jinshan County, Shanghai, China
Date Summary Prepared: February 15, 1996
2 . Name of the Device:
Sunmax Enterprise Shanghai Co., Ltd. Vinyl Patient Examination Gloves - Powdered
3. Predicate Device Information:
Honyee Vinyl Patient Examination Gloves, K#893822 Cheer & Merit Vinyl Patient Examination Gloves, K#941809
4 . Device Description:
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
5 . Intended Use:
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel the patient's body, and fluids, waste or environment.
ર. Comparison to Predicate Devices:
Sunmax Enterprise Shanghai Co., Ltd. Vinyl Patient Examination Gloves-Powdered, is substantially equivalent in safety and effectiveness to the Honyee Vinyl Patient Examination Glove and the Cheer & Merit Patient Examination Glove.
1
Discussion of Non-Cliniqual reats rests restorned for Determination or Subscuntie) Busqualence are as follows?
- 2 -
The standards used for Sunmax Enterprise Shanghai Co., glove production are based on ASTM-D-5250-92. Ltd. All testing neets requirements for Physical Dimensions and Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
Sunmax Enterprise Shanghai Co., Ltd. operates in compliance
with FDA's GMPs. with FDA's GHPs.
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is no hypoallergenic claim.
9 . Conclusions:
:
···
Sunmax Enterprise Shanghai Co., Ltd. Vinyl Patient Examination applicable 21 CFR references applicable 27 CFR references, and, meets pinhole cequirements. biocompatibility 1400 requirements labeling and clains 요. 합 shown by data in Section 7. Thare safety/efficacy issues or new claims from the "substantial equivalence" products cited.
Annie Liu
LIU
B. 16,1996
DATE: