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EKG Glove

FDA UDI

Class II (US FDA UDI)

by Ineedmd Holdings, Inc.

Identity

Trade Name
EKG Glove FDA UDI
Generic Name
Electrocardiographic electrode, single-use FDA UDI
Device Name
EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, collect data for an EKG - Large size FDA UDI
Model / Reference
Large FDA UDI
Description
EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, collect data for an EKG - Large size FDA UDI

Identifiers

Primary DI / UDI-DI
00862795000418 FDA UDI
510(k) Number
K033559 FDA UDI
K100315 FDA UDI
FDA Product Code
DRX FDA UDI
GMDN Term
Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic electrode, single-use

EKG Glove by Ineedmd Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic electrode, single-use.

Cleared under the same submission

K033559 also covers:

K100315 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ineedmd Holdings, Inc.

Sources (1)

  • FDA UDI 8c367b3a-8156-4f02-8cc7-fea15ac35caa 35 fields · synced May 30, 2026